[Federal Register Volume 77, Number 149 (Thursday, August 2, 2012)]
[Rules and Regulations]
[Pages 45927-45944]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-18764]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 807
[Docket No. FDA-2009-N-0114]
RIN 0910-AF88
Implementation of Device Registration and Listing Requirements
Enacted in the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, the Medical Device User Fee and Modernization Act
of 2002, and Title II of the Food and Drug Administration Amendments
Act of 2007
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is amending its
regulations to reflect recent statutory amendments to the device
registration and listing provisions of the Federal Food, Drug, and
Cosmetic Act (FD&C Act). The Food and Drug Administration Amendments
Act of 2007 (FDAAA), enacted on September 27, 2007, amended the FD&C
Act by requiring domestic and foreign device establishments to begin
submitting their registration and device listing information to FDA by
electronic means rather than on paper forms, and also specified the
timeframes when establishments are required to submit such information.
In addition, this final rule would facilitate FDA's collection of
additional registration information from foreign establishments as
required by the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 (Bioterrorism Act). The final rule will update
certain provisions in the regulations to improve the quality of
registration and listing information available to FDA. FDA relies on
having complete and accurate registration and listing information in
order to accomplish a number of important public health objectives.
DATES: This final rule is effective October 1, 2012.
FOR FURTHER INFORMATION CONTACT:
Ann Ferriter, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, Rm. 2680, Silver
Spring, MD 20993-0002, 301-796-5686; and
Stephen Ripley, Center for Biologics Evaluation and Research (HFM-17),
Food and Drug Administration, 1401 Rockville Pike, Suite 200N,
Rockville, MD 20852-1448, 301-827-6210.
SUPPLEMENTARY INFORMATION:
Table of Contents
I. Background
II. Overview of the Final Rule
III. Comments on the Proposed Rule
IV. Legal Authority
V. Analysis of Economic Impacts
VI. Paperwork Reduction Act of 1995
VII. Environmental Impact
VIII. Federalism
IX. References
I. Background
We originally published establishment registration regulations for
medical devices in the Federal Register of September 3, 1976 (41 FR
37458) (proposed rule) and August 23, 1977 (42 FR 42520) (final rule),
and device listing regulations in the Federal Register of September 30,
1977 (42 FR 52808) (proposed rule), and August 25, 1978 (43 FR 37990)
(final rule).
These regulations called for establishment registration and device
listing information to be submitted to the Center for Devices and
Radiological Health (CDRH) on several paper forms: FDA 2891,
Registration of Device Establishment; FDA 2891a, Annual Registration of
Device Establishment; and FDA 2892, Device Listing. Once these forms
were completed and submitted to FDA, FDA then forwarded them to a data
entry contractor who entered the information into FDA's device
registration and listing database.
In June 2002, section 321 of the Bioterrorism Act (Pub. L. 107-188)
amended section 510(i) of the FD&C Act (21 U.S.C. 360(i)) to require
those foreign establishments who are required to register with FDA to
do so by electronic means, and to include additional information
identifying certain parties involved in the importation of the foreign
establishment's devices into the United States as part of their
registration. Subsequently, in October 2002, section 207 of the Medical
Device User Fee and Modernization Act (MDUFMA) (Pub. L. 107-250)
further amended section 510 of the FD&C Act by extending the
requirement for electronic submission of registration information to
include domestic firms as well as foreign firms. However, when adding
these new electronic submission requirements, which appear in section
510(p) of the FD&C Act, Congress chose to delay their implementation so
that FDA would have an opportunity to first put systems in place to
accommodate the electronic receipt of registration information. This
was accomplished by including a
[[Page 45928]]
requirement in section 510(p) of the FD&C Act for the Secretary of the
Department of Health and Human Services (the Secretary) to make a
finding that the electronic receipt of registration information was
feasible before implementing electronic registration.
As reflected in FDAAA (Pub. L. 110-85), the most recent legislation
establishing changes to FDA's device registration and listing program,
FDA has now developed a system that makes the electronic receipt of
device registration and listing information feasible. FDAAA amended
section 510(p) of the FD&C Act by eliminating the need for a
feasibility finding, and requiring both foreign and domestic
establishment registration and device listing information to be
submitted using electronic means unless FDA grants a waiver request. In
accordance with FDAAA, FDA's Unified Registration and Listing System
(FURLS) for devices, which is a new Internet-based system, became
operational on October 1, 2007. FDA believes this electronic system
will ultimately make the process of submitting registration and listing
information for devices more efficient for industry and will provide
faster access to this information for both FDA and industry.
In addition, the new electronic system will allow FDA to more
effectively gather information concerning marketed devices. We rely on
having complete and accurate registration and listing information to
accomplish a number of important statutory and regulatory objectives.
For example, we use registration and listing information to:
Identify establishments producing marketed medical
devices;
Identify establishments producing a specific device when
that device is in short supply or is needed for a national emergency.
This information helps us facilitate prompt shipment of devices to the
places where they are needed most. For example, during a bioterrorism
incident, we could use device listing information to identify
establishments that could be helpful in preventing or counteracting the
deadly effects of biological weapons; with this information, we could
facilitate prompt shipment of the devices as needed;
Facilitate the recall of devices marketed by owners or
operators of device establishments;
Identify and catalogue marketed devices;
Administer our postmarketing surveillance programs for
devices;
Identify devices marketed in violation of the law;
Identify and control devices imported or offered for
import into the country from foreign establishments; and
Schedule and plan inspections of registered establishments
under section 704 of the FD&C Act (21 U.S.C. 374).
We also rely on registration and listing information to help us
comply with several other statutory provisions. For example, we use
this information to generate accurate estimates of the number of
businesses that are affected by our rulemaking activities. These
estimates help us assess the impact of our regulations on regulated
industry, which we are required to do under the Regulatory Flexibility
Act of 1980 (Pub. L. 96-354) (5 U.S.C. 601-612), as amended by the
Small Business Regulatory Enforcement Fairness Act of 1996 (Title II of
Pub. L. 104-121); the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4) (2 U.S.C. 1501 et seq.); the Paperwork Reduction Act of 1995
(the PRA) (44 U.S.C. 3501-3520); Executive Order 12866 (September 30,
1993); and the Congressional Review Act (section 251 of Pub. L. 104-
121).
Registration and listing information will continue to be used for
all of the important public health purposes outlined in this document.
The electronic submission of registration and listing information
allows us to use such information more quickly and effectively to carry
out all of the activities described in this document.
In addition, electronic submission of registration and listing
information furthers the purpose of the Government Paperwork
Elimination Act of 1998 (Pub. L. 105-277, Title XVII) (GPEA). GPEA
requires Federal Agencies to give persons who are required to maintain,
submit, or disclose information, the option of doing so electronically
when practicable as a substitute for paper, and to use electronic
authentication (electronic signature) methods to verify the identity of
the sender and the integrity of the electronic content. We believe that
electronic submission of registration and listing information furthers
the purpose of this law and makes the registration and listing
processes more efficient and effective both for industry and us.
To implement the FDAAA and Bioterrorism Act amendments to section
510 of the FD&C Act, FDA published in the Federal Register of March 26,
2010 (75 FR 14510), a proposed rule to amend its regulations governing
medical device establishment registration and device listing (the March
2010 proposed rule). The comment period closed on June 24, 2010.
II. Overview of the Final Rule
A. Significant Changes to the Proposed Rule
FDA made no significant changes to the proposed rule.
B. Highlights of the Final Rule
1. Switch to an Electronic Registration and Listing System
This final rule updates the regulations to conform to the
requirement in section 510(p) of the FD&C Act, as amended by FDAAA,
that registration and listing information be provided to FDA
electronically unless FDA grants a request for a waiver.
As part of the new electronic registration and listing system, each
owner or operator establishes an account on FDA's online device
establishment registration and device listing system, FURLS, which the
owner or operator uses to create and update his or her device
establishment registration and device listing information. Information
submitted to FDA prior to September 15, 2007, has already been migrated
to the new FURLS electronic database and thus there is no need for
owners or operators to reenter this information.
In accordance with section 510 of the FD&C Act, as amended by
sections 222 through 224 of FDAAA, device establishment owners and
operators have been using FURLS to submit their establishment
registration and device listing information electronically since the
system became operational on October 1, 2007. In addition, in
accordance with section 510(p) of the FD&C Act, as amended by FDAAA
section 224, FDA is granting waivers from the new electronic submission
requirements only to those owners or operators for whom electronic
registration and listing is not reasonable.
2. Foreign Establishment Registration and Listing Requirements of the
Bioterrorism Act
Before its devices will be allowed into the United States, each
foreign establishment that is required to register must supply to FDA
the registration information required by part 807, including the name
and contact information for its U.S. agent. Section 321 of the
Bioterrorism Act affected foreign establishment registration in part by
amending section 510(i) of the FD&C Act to require, as part of an
establishment's registration, the name of each importer of the device
that is known to the establishment and the name of each person who
imports or offers to import the device into the
[[Page 45929]]
United States. This final rule amends part 807 to reflect in our
regulations the Bioterrorism Act requirement that foreign
establishments whose devices are imported or offered for import into
the United States must identify: (1) All importers known to the foreign
establishment and (2) the name of each person who imports or offers to
import the foreign establishment's device into the United States. The
final rule revises Sec. 807.3 to add specific definitions for these
two new categories of information that need to be submitted by foreign
establishments.
The final rule eliminates the exemption in Sec. 807.40(a) for
foreign establishments whose devices enter a foreign trade zone and are
re-exported from the foreign trade zone without entering U.S. commerce,
and also eliminates the exemption in Sec. 807.40(c) for devices that
are imported under section 801(d)(3) of the FD&C Act (21 U.S.C.
381(d)(3)). Removing the exemptions from registration and listing
requirements for devices entering foreign trade zones and for products
imported under section 801(d)(3) of the FD&C Act is consistent with
Congress' desire, as reflected in the Bioterrorism Act, to increase the
Nation's ability to prepare for and effectively respond to bioterrorism
and other public health emergencies by requiring foreign establishments
to provide more, rather than less, information for imported products.
For example, registration and listing information for devices imported
into foreign trade zones and devices imported under section 801(d)(3)
of the FD&C Act will help us identify and contact foreign
establishments that export to the U.S. devices for which there may be a
domestic shortage in an emergency.
3. Change in Requirements Relating to Contract Manufacturers and
Sterilizers
The final regulation also amends part 807 to modify Sec.
807.20(a)(2) and removes Sec. 807.20(c)(1) and (c)(2) such that all
contract manufacturers and contract sterilizers are required to
register their establishments and list their devices. FDA relies on
having a complete and accurate registration of device establishments
and listing information for devices processed at those establishments
in order to accomplish a number of important statutory and regulatory
objectives. For example, when an establishment experiences a problem,
it can have a significant impact on the product lines for one or
multiple firms for which it is contracted to provide manufacturing or
sterilization services. Knowing which products are manufactured or
sterilized at the affected site could facilitate the recall of the
impacted devices. FDA also believes that knowing that these
manufacturing sites exist would be critical information when a device
is in short supply or needed in the event of a national emergency.
4. Requiring Submission of the FDA Product Code Assigned to a Device
Rather Than the Classification Name and Number
The new electronic system requires exempt devices to be identified
by product code rather than by classification name and number. The
product code is already requested for such devices. This change to the
regulation codifies the existing practice.
5. Requiring Submission of the 510(k) or the Humanitarian Device
Exemption (HDE) Number for Non-Exempt Device Listings
Section 807.25(g)(4) of the final regulation also codifies the
practice of including the 510(k) number when listing a medical device
that has gone through premarket clearance or the approved HDE number in
the electronic device registration and listing system. This change also
provides FDA with a tool to help ensure that devices that lack a
required premarket clearance or premarket approval are not marketed.
6. Identification of a Contact Person to Administer the Electronic
System Accounts
As a result of the passage of FDAAA, FDA began collecting device
registration and listing information using FURLS beginning in October
2007. When using FURLS, an owner or operator needs to identify not only
an official correspondent for the establishment but also a contact
person for the owner or operator. The contact person is the only person
who can administer the owner or operator's user accounts in FURLS.
In instances where owners or operators have only one establishment,
they may choose the same person to serve as both the contact person for
the user account and the official correspondent for the establishment.
For owners or operators with multiple establishments, the contact
person for the owner or operator may also serve as the official
correspondent for any or all of the owner or operator's establishments.
Alternatively, using the accounts management software for FURLS, the
owner or operator may create subaccounts in which different official
correspondents are identified for each establishment.
Proper control of access to accounts and control of the ability to
update an establishment's online information is necessary to avoid
errors. Therefore, the final rule requires that each owner or operator
identify only one contact person within the owner or operator's
organization who will be responsible for creating the master account in
FURLS for the owner or operator and assigning subaccounts to each
establishment, if needed. Once the contact person creates the master
account and any needed subaccounts, the official correspondent can then
use the accounts to submit the owner or operator's establishment
registration and device listing information to FDA.
7. Establishment Operations Will Be Reported Through Device Listing
The final rule requires owners or operators to identify the
operations or activities their establishments engage in only as part of
their device listings. This is because the new electronic system has
been designed to automatically migrate the information provided in the
device listing to the owner or operator's registration, thus saving the
owner or operator from having to provide the same information twice.
Because under the new system owners or operators would only have to
supply such information once, this change will save time and help avoid
inconsistencies between the registration and listing information for a
single establishment.
8. Registration Fees
FDAAA section 212 requires that certain medical device
establishments pay a registration user fee when they initially register
with FDA and for each annual registration thereafter. The final rule,
therefore, removes the sentence at the beginning of Sec. 807.20(b)
that states ``[n]o registration or listing fee is required.''
9. Definition of Restricted Devices
The final rule revises the definition of ``restricted device'' in
Sec. 807.3(i) to more accurately reflect the provisions of the FD&C
Act that provide us with authority to restrict devices.
III. Comments on the Proposed Rule
In the March 2010 proposed rule, FDA proposed to amend its
regulations governing medical device establishment registration and
device listing. FDA provided 90 days for the submission of comments
from interested parties. FDA received three sets of comments which FDA
summarizes and discusses in this section of this document.
(Comment 1) Two comments objected that it is not necessary for
contract manufacturers and contract sterilizers to list all products,
since these contractors
[[Page 45930]]
are typically not responsible for putting the contracted products into
the marketplace. The comments stated that such a requirement would: (1)
Duplicate information already submitted by the manufacturer; (2)
increase the risk that inaccurate information was submitted to FDA
because contract manufacturers are not in the best position to inform
FDA when commercial distribution of a device has commenced, ceased, or
resumed; and (3) reveal confidential business partnerships to
competitors.
(Response) FDA disagrees with these comments. FDA does not consider
the requirement that contract sterilizers and manufacturers list
devices to be duplicative. While registration provides valuable
information regarding, for example, the location of device
establishments, this value is limited if we do not also know what
devices are being manufactured and sterilized at the establishments.
FDA relies on having a complete and accurate registry of device
establishments and a list of devices processed at those establishments
in order to accomplish a number of important statutory and regulatory
objectives. For example, having basic information about where devices
are made and cleaned will enable us to respond in a more timely and
effective fashion in the case of an adverse event or defect associated
with a particular device or if there is a shortage of a particular
device in the event of a national emergency.
FDA does not believe that the final rule will increase the risk
that inaccurate listing information is submitted to FDA. Contract
manufacturers and contract sterilizers, as with other establishments,
will be required to register and list within 30 days of entering into
such operation and review and update listing information annually.
Contracting entities will be responsible for providing accurate
information to FDA and should know what devices they manufacture or
sterilize at their establishment.
Finally, requiring contract manufacturers and sterilizers to submit
listing information to FDA will not reveal confidential business
partnerships to competitors. Under 21 CFR 20.116, public disclosure of
establishment registration and device listing information is governed
entirely by Sec. 807.37, which addresses how such information will be
subject to inspection in accordance with section 510(f) of the FD&C
Act. FDA has revised Sec. 807.37 to reflect its plans to exclude from
public inspection or posting on the FDA Web site brand names and
premarket submission numbers of devices manufactured or sterilized by a
contractor that would reveal confidential business relationships, and
plans to add a mechanism in FURLS to allow entities to indicate whether
they believe information should not be made public under this standard.
We also revised Sec. 807.37 to make clear that FDA-assigned listing
numbers will also not be publicly available or posted on the public
FURLS Web site. Listing numbers serve important governmental functions
that may be harmed if they were made public.
(Comment 2) One comment questioned requiring contract manufacturers
to register because contract manufacturers have a one-to-one
relationship with finished device manufacturers that would not be of
benefit in providing enhanced manufacturing when devices are in short
supply.
(Response) FDA disagrees. By statute, all establishments engaged in
the manufacture, preparation, propagation, compounding, or processing
of a device (including repackaging and relabeling) are required to
register unless specifically exempted by regulation. See sections
510(a) to (d), (i) and (g) of the FD&C Act. Contract manufacturers are
engaged in these activities, and FDA believes that the registration of
their establishments is not unnecessary to the protection of the public
health. For example, this information would provide us with basic
information about the entities that make devices, facilitating a timely
and effective response to adverse events, shortage, or other device
problems associated with one of these establishments, in addition to
potentially assisting with device shortages. The information would also
assist us in our fundamental regulatory activities, such as planning
and scheduling inspections.
(Comment 3) One comment suggested that FDA add a new registration
type for foreign establishments that import devices into foreign trade
zones.
(Response) FDA believes that foreign establishments that import
devices into foreign trade zones should be treated the same as other
establishments that must register and list. FDA agrees, however, that
it is important to capture whether an establishment is importing
devices into foreign trade zones and will add an establishment type to
the existing list of establishment types in FURLS to cover this
activity.
(Comment 4) One comment disagreed with FDA's proposed revocation of
the exemption in Sec. 807.40(a) for devices from foreign
establishments that enter a foreign trade zone and are re-exported from
that foreign trade zone without having entered U.S. commerce. The
comment questioned whether the Bioterrorism Act would require the
revocation of the exemption and whether the U.S. Customs and Border
Protection Customs-Trade Partnership Against Terrorism and the Customs
Advance Manifest Rule would provide FDA access to verification that
devices for export are re-exported and information about the shipper,
cargo, and consignee.
(Response) FDA disagrees. The removal of the exemption increases
the United States' ability to defend against and respond to
bioterrorism by providing FDA with additional information regarding
foreign establishments and devices manufactured at those establishments
that are shipped into the United States, which is consistent with the
goals of the Bioterrorism Act. For example, this information could be
used to address a device shortage in an emergency.
(Comment 5) One comment urged FDA to revise Sec. 807.40 to include
a list of activities that require foreign establishment registration
that parallels the list in Sec. 807.20(a) of activities that require
registration of domestic establishments.
(Response) FDA declines to revise the rule as suggested by the
comment, as the list of activities in Sec. 807.20(a), which is not
all-inclusive, already applies to both domestic and foreign
establishments. FDA does want to emphasize, however, that it considers
a foreign establishment that only exports devices to the United States
to be engaged in the manufacture, preparation, propagation,
compounding, or processing of a device, and it therefore must register
and list. Further, Sec. 807.40(c) prohibits a device from being
imported or offered for import into the United States unless it is the
subject of a device listing and is manufactured, prepared, propagated,
compounded, or processed at a registered foreign establishment. Thus, a
device may not enter the country unless valid registration and listing
information are provided. This information is used, for example, by
verifying that medical devices entering the United States are exported
from legitimate sources, are not counterfeit, and are legally marketed
in the United States.
(Comment 6) One comment urged that Sec. 807.25(a) discuss the part
11 (21 CFR part 11), Electronic Records, Electronic Signatures
responsibilities of a party using the FDA-supplied FURLS system.
(Response) FDA declines to revise the rule as suggested by the
comment. Under Sec. 807.25(a), the submission of registration and
listing information must be made in accordance with part 11, with
certain exceptions. See discussion
[[Page 45931]]
in the preamble to the March 2010 proposed rule (75 FR 14510 at 14523)
and FDA's guidance on part 11 referenced therein.
(Comment 7) Citing the preamble to the March 2010 proposed rule (75
FR 14510 at 14516), one comment expressed concerns about combination
products having to register and list with, and pay fees to, more than
one Center. The comment urged FDA to add a flag to a listing that
identifies a combination product.
(Response) As reflected in the preamble to the March 2010 proposed
rule, the Agency is currently working to develop and implement a more
streamlined approach to facility registration and product listing for
combination products. User fees are outside the scope of this rule. We
intend to address these issues in the future. For efficient, effective
regulation of combination products, FDA intends to add a flag to
identify whether a listing is for a combination product.
(Comment 8) One comment urged FDA to revise Sec. 807.25(g)(4) to
list the submission types.
(Response) FDA declines to revise the rule as suggested by the
comment. However, we revised Sec. Sec. 807.25(g)(4) and 807.3(w) to
make clear that they include the premarket submission number for
granted de novo petitions for classification under section 513(f) of
the FD&C Act (21 U.S.C. 360c(f)), which are currently given a number
preceded by the letter ``K.''
(Comment 9) One comment urged that owner-operators be given the
ability to assign individuals to have ``View Only'' access to FURLS.
(Response) This comment asks for a change beyond the scope of this
rulemaking.
(Comment 10) One comment urged that private label manufacturers
should not have to submit brand names considered trade confidential
under Sec. 807.25(b). Alternatively, the comment urged FDA to restrict
access to information considered to be trade confidential to FDA and
the FURLS account owner.
(Response) FDA declines to remove this requirement from the rule.
Requiring private label manufacturers to submit brand names to FDA will
not reveal this information to the public. FDA has revised Sec. 807.37
to reflect its plans to exclude from public inspection or posting on
the FDA Web site brand names and premarket submission numbers of
devices marketed by a private label manufacturer that would reveal
confidential business relationships, and plans to include a mechanism
in FURLS to allow entities to indicate whether they believe information
should not be made public under this standard.
(Comment 11) One comment urged FDA to describe the timeline that
applies to establishment registration and provide acknowledgment of
successful registration.
(Response) FDA agrees that describing the timeline that applies to
establishment registration is important, which is why Sec. 807.22,
``Times for establishment registration and device listing,'' provides
timelines for registration. To be clear that Sec. 807.28 governs
conditions that require that listing information be updated, and not
the time at which listing must be updated, which is governed by Sec.
807.22, we changed four occurrences of ``when'' to ``if'' in Sec.
807.28(a) and (b). We also want to be clear that, though changes to
listing information must be reported to FDA between October 1 and
December 31 of each year, the information that must be reported
includes any changes that occur since the previous annual listing. For
example, if a manufacturer begins producing a device in January and
ceases (temporarily or permanently) producing such device in June, this
would have to be reported to FDA between October 1 and December 31 of
that year.
When an establishment successfully completes a process (e.g.,
registers and lists for the first time, completes annual registration,
creates a new listing, etc.) in FURLS, a confirmation screen appears
indicating successful completion of the process. In some cases, the
establishment may also receive an email in addition to the confirmation
screen. These instances include when an establishment registers and
lists for the first time and when FDA sends an email to confirm that
they have completed their annual registration. If an establishment does
not successfully make it through the process it is trying to complete
(e.g., registering and/or listing devices, updating information in the
software, etc.), it would not be provided with an email or confirmation
screen and would know it was not successfully processed or that an
error occurred.
(Comment 12) One comment urged FDA to make available a test or
training version of FURLS online that provides access to simulated data
or an instruction manual that includes screen shots of the steps in the
registration and listing process.
(Response) FDA agrees. Already available, the FURLS Device
Registration and Listing Module (DRLM) has online instructions that
include screen shots that may be viewed by clicking on the help icon
located near the top right of the screen. FDA's DRLM Web site: (http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/HowtoMarketYourDevice/RegistrationandListing/default.htm) provides
instruction on who must register and list, who must pay the annual
registration user fee and how to register, list, and pay the fee.
Assistance is available by sending an email to [email protected] or
by calling 301-796-7400.
IV. Legal Authority
We have the legal authority to amend our regulations on foreign and
domestic establishment registration and listing for human devices. The
statutory basis for our authority includes sections 201, 301, 501, 502,
510, 512, 513, 515, 519-520, 701, 704, 801, and 903 of the FD&C Act (21
U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i-360j, 371, 374, 381,
and 393); and sections 361 and 368 of the Public Health Service Act (42
U.S.C. 264 and 271) (the PHS Act).
Section 510(c) of the FD&C Act requires every person upon first
engaging in the manufacture, preparation, propagation, compounding, or
processing of a device to immediately register with the Secretary his
name, place of business, and the establishment. The provisions in
section 510(b) and (d) of the FD&C Act require annual registration and
registration of additional establishments, respectively. As amended by
section 222 of FDAAA, section 510(b) of the FD&C Act requires that
annual registration take place during the period beginning on October 1
and ending on December 31 of each year. Section 510(i) of the FD&C Act,
as amended by section 222 of FDAAA, requires any establishment within
any foreign country engaged in the manufacture, preparation,
propagation, compounding, or processing of a device that is imported or
offered for import into the United States, upon first engaging in such
activity, to immediately register with the Secretary through electronic
means, and thereafter to register annually during the period beginning
on October 1 and ending on December 31 of each year. These provisions,
together with section 701(a) (among others) of the FD&C Act (21 U.S.C.
371(a)), authorize us to require the submission of the registration
information specified in the final rule. The information specified in
this final rule will help us identify who is manufacturing, preparing,
propagating, compounding, processing, repacking, or relabeling devices
and where those operations are being performed. In
[[Page 45932]]
addition, some information (e.g., official correspondent information)
would help us communicate with establishments more effectively and
schedule inspections more efficiently.
Section 510(j)(1) of the FD&C Act requires every person who
registers to file with the Secretary of the Department of Health and
Human Services (the Secretary), at the time of registration, a list of
all devices that are being manufactured, prepared, propagated,
compounded, or processed by the registrant for commercial distribution.
That list must be prepared in the form and manner prescribed by the
Secretary and must be accompanied by a copy of labeling (or the label
and package insert) and, in some cases, advertising. Section 510(j)(2)
of the FD&C Act, as amended by section 223 of FDAAA, requires each
person who registers with the Secretary under this section to report
listing information updates once each year during the period beginning
on October 1 and ending on December 31 of each year. Listing
information gives us a current inventory of marketed devices. These
provisions and others of the FD&C Act, together with section 701(a) of
the FD&C Act, provide authority for requiring the submission of the
listing information set forth in this final rule. The device listing
information specified in this final rule will help us: (1) Develop a
more current, robust inventory of devices as a counter-terrorism
measure; (2) administer our postmarket surveillance programs more
effectively; (3) facilitate recalls of products; (4) identify devices
in short supply in the event of a national emergency; and (5) identify
devices marketed in violation of the FD&C Act.
Section 510(p) of the FD&C Act, as amended by section 224 of FDAAA,
requires that registration and listing information be submitted
electronically, subject to FDA's grant of waivers to individual
requestors who meet the criteria set forth in section 510(p).
Electronic receipt of registration and listing information will enable
us to shift resources from performing more ministerial tasks, such as
data entry, to pursuing important public health objectives such as
those described in section I of this document. Electronic receipt of
registration and listing information also will help us with the
efficient enforcement of the FD&C Act because we would be able to
distinguish situations where there has been noncompliance with
registration and listing requirements from situations where there have
been no changes in information. The failure to register or list is a
prohibited act under section 301(p) of the FD&C Act (21 U.S.C. 331(p))
and the failure to do either generally renders a device misbranded
under section 502(o) of the FD&C Act (21 U.S.C. 360(o)).
V. Analysis of Economic Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L.
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this final rule is not a significant
regulatory action under Executive Order 12866.
The Regulatory Flexibility Act requires Agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. Because the cost of this final rule is expected to
be very small, the Agency certifies that the final rule will not have a
significant economic impact on a substantial number of small entities.
Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires
that Agencies prepare a written statement, which includes an assessment
of anticipated costs and benefits, before proposing ``any rule that
includes any Federal mandate that may result in the expenditure by
State, local, and tribal governments, in the aggregate, or by the
private sector, of $100,000,000 or more (adjusted annually for
inflation) in any one year.'' The current threshold after adjustment
for inflation is $139 million, using the most current (2011) Implicit
Price Deflator for the Gross Domestic Product. FDA does not expect this
final rule to result in any 1-year expenditure that would meet or
exceed this amount.
We received no comments on the analysis of impacts in the March
2010 proposed rule. We have updated but have not made substantial
changes to the analysis for this final rule. We used the same baseline
as we did in the proposed rule; costs and benefits are estimated
relative to the system of paper forms that existed prior to FDA's
Internet-based electronic listing and registration system. The new
system became operational on October 1, 2007.
We contracted with the Eastern Research Group, Inc. (ERG), to
collect data, interview industry experts, and estimate the costs and
benefits of the rule. The analysis in support of the effects of the
final rule (ERG Memo) is on file with the Division of Dockets
Management. ERG identified several very small impacts, both costs and
benefits, most of which are too small to generate meaningful numeric
estimates.\1\ The ERG Memo identified recurring costs associated with
this final rule, plus additional costs that would not apply to U.S.
establishments. After updating ERG's findings with more recent cost
information, we find annual costs of $340,000 associated with this
final rule, and an additional $138,000 that would only affect non-U.S.
establishments. We were unable to quantify specific benefits
attributable to the final rule, but the ultimate use of electronic
registration and listing data, the mandate under the Bioterrorism Act
to collect additional pieces of registration data, and the requirement
under the Bioterrorism Act and FDAAA that information be submitted to
FDA electronically justify taking this action.
---------------------------------------------------------------------------
\1\ ERG memorandum from Cal Franz, et al., September 15, 2008
(hereinafter referred to as ERG Memo), p. 1.
---------------------------------------------------------------------------
A. The Need for Regulation
As discussed elsewhere in this preamble, section 224 of FDAAA
amended section 510(p) of the FD&C Act to require establishment
registrations and device listings to be submitted to FDA by electronic
means unless the Secretary grants a waiver from electronic submission
requirements. We currently maintain databases that contain
establishment registration and device listing information obtained from
owners and operators of device establishments. Prior to FDAAA, these
databases relied on paper forms submitted by the owners and operators
to us, which were then forwarded by us to a data entry contractor for
input into our device registration and listing databases.
Our device registration and listing databases play an important
role in our efforts to accomplish many regulatory and statutory
objectives. For example, we can use this information to identify device
manufacturers to facilitate recalls or information alerts in the case
of potential safety concerns. We also use it to plan and conduct
inspections, administer postmarket surveillance, generate estimates of
the number of businesses that are affected by our rulemaking, and to
otherwise exercise competent oversight of the device industry.
The quality and completeness of these databases depends on prompt
[[Page 45933]]
submission of information and the immediate inclusion of the data in
our system. Under a paper-based registration and listing system, we
were unable to readily verify the accuracy of the information submitted
and, in some instances, manufacturers were not timely in informing us
of changes. In addition, because we were using physical paper forms, it
was possible for information to be mishandled or lost before being
added to the system, thereby further reducing the reliability of the
databases.
In accordance with FDAAA, the Agency began collecting device
establishment registration and device listing information using FURLS,
FDA's new Internet-based electronic device establishment registration
and device listing system which became operational on October 1, 2007.
The electronic submission of information makes the registration and
listing process more efficient for industry and allows us to review and
use such information more quickly, thus helping to ensure that medical
devices will be safe and effective.
Despite the obvious public health advantages to society of using an
electronic device registration and listing system, the private returns
alone would not be adequate to move the entire device industry to a new
registration and listing format that would meet the requirements of
section 510(i) and (p) of the FD&C Act. Because the social benefits are
largely external to the firms, the large number of entities operating
individually cannot be expected to voluntarily move to a new uniform
standard. Few entities would choose to adopt a new format without
significant private benefits.
B. Background
Revisions to the existing device registration and listing
regulations would affect owner-operators of all registered device
establishments. Based on a review of our internal databases on
September 12, 2011, there are approximately 21,254 owner-operators of
approximately 24,000 registered device establishments, and 121,300
listed devices. Of the 24,000 registered establishments, approximately
14,000 are registered as domestic and 10,000 are registered as foreign.
Under the existing regulations, with certain exceptions, owners or
operators of establishments that engage in the manufacture,
preparation, propagation, compounding, assembly, or processing of a
device intended for human use must, in addition to other requirements,
register their establishments and submit listing information for each
of their devices in commercial distribution. Foreign device
establishments engaged in the manufacture, preparation, propagation,
compounding, or processing of a device that is imported or offered for
import into the United States must comply with the registration and
listing requirements, including the requirement to identify a U.S.
agent. Until the recent change to electronic submissions mandated by
section 224 of FDAAA, all domestic and foreign registration and listing
information was submitted using paper forms.
C. The Final Regulation
A major objective of this final rule is to update FDA's regulations
at part 807 to reflect the requirement for electronic submission of
establishment registration and device listing information as required
by FDAAA. A paper-based system of registering and listing is costly. It
does not facilitate timely updates, which does not allow for the best
use of these data in inspections and recalls. Electronic submission of
registration and listing information improves the quality and
timeliness of information available to FDA. In addition, a system of
electronic registration and listing improves the quality and timeliness
of information available to health care professionals and consumers.
Furthermore, to the extent that these quality improvements to the
registration and listing process facilitate device recalls, complement
postmarketing surveillance programs, help ensure the safety of imported
devices, improve the scheduling and planning of inspections, and
otherwise assist the Agency in carrying out its statutory and
regulatory objectives, there is a broad public health benefit.
Moreover, the development and maintenance of high quality databases of
information about devices and device establishments would enhance
future uses of technology in the delivery of health care. An electronic
database that contains current and accurate information about devices
could, for example, facilitate the development of technology that would
allow for communication among devices, giving them additional
functionality and the potential for interoperability.
This final regulation will also slightly modify the types of
information that would need to be submitted as registration and listing
information. However, these modifications would be minor and are
generally consistent with achieving a more accurate and useful database
of device industry information.
D. Estimated Impacts
The ERG Memo identifies eight areas where revisions to the current
device registration and listing provisions may affect the cost of
compliance.\2\ These impacts would stem from provisions associated
with:
---------------------------------------------------------------------------
\2\ ERG memo, p. 3.
---------------------------------------------------------------------------
The creation of an account on FURLS;
The requirement for submission of additional information
as part of the annual registration process;
Modifications to requirements relating to registration
information updates;
The requirement for submission of additional information
when listing a device;
Changes relating to the requirement for review and update
of device listing information;
The waiver from the requirement to register and list by
electronic means;
The elimination of the exemptions from registration and
listing requirements for foreign establishments whose devices enter a
foreign trade zone and are re-exported from the foreign trade zone
without having entered U.S. commerce and the exemption for devices that
are imported under section 801(d)(3) of the FD&C Act (import-for-export
provision); and
The elimination of the exemption from registration and
listing requirements for contract manufacturers and contract
sterilizers who do not commercially distribute the devices.
Because most of the identified regulatory impacts only slightly
increase or decrease the costs of registering and listing, sometimes
involving offsetting impacts, we present the impacts grouped by the
eight impact areas identified previously, as opposed to trying to
present the impacts as distinct groups of costs and benefits.
1. Creation of FURLS Accounts
Under the final rule, establishments go through the one-time
process of creating a FURLS account. According to ERG, the costs
associated with setting up the FURLS account are negligible.\3\
---------------------------------------------------------------------------
\3\ ERG memo, p. 4.
---------------------------------------------------------------------------
2. Changes to Annual Registration Information
This final rule could affect the cost to establishments by changing
the information they submit in the annual registration process. ERG
found that differences in the information collected currently and the
requirements under the final rule would be minor and should not
increase the time spent
[[Page 45934]]
completing the registration.\4\ Some of the additional information in
the final rule, such as email addresses for the establishment's
official correspondent and owner-operator and the universal resource
locator (URL) for the establishment's Web site, are currently collected
by FDA and there will be little if any additional cost for those
establishments not currently providing this information. There will be
modest savings associated with the annual registration process, as
establishments will be able to access and edit registration information
online and will no longer have to wait for physical forms to be mailed
from FDA, review them, make edits, and mail the forms back to FDA.
---------------------------------------------------------------------------
\4\ ERG memo, p. 4.
---------------------------------------------------------------------------
As amended by section 321 of the Bioterrorism Act, section 510(i)
of the FD&C Act requires foreign establishments whose devices are
imported or offered for import to the United States to identify and
provide contact information for importers of the establishment's device
that are known to the establishment and also those persons who import
or offer for import the device into the United States. According to the
ERG memo, foreign establishments identifying importers known to them
and persons who import or offer for import the establishments' devices
would typically be identifying one or two entities of each type with
readily available contact information, so the impact would be
negligible.\5\ OMB Circular A-4 directs us to carefully evaluate new
U.S. rules that might act as non-tariff barriers to imported goods. As
the cost to these foreign establishments will be quite small and will
not have a significant adverse effect on trade, the impact on U.S.
consumers from this provision will be negligible.
---------------------------------------------------------------------------
\5\ ERG memo, p. 5.
---------------------------------------------------------------------------
3. Changes Relating to the Requirement To Update Registration
Information
Under Sec. 807.22(b)(2), establishments would be required to
update their registration within 30 days if their registration
information were to change. Current Sec. 807.26 requires that
establishments update registration information for a change in
ownership or a change in the location of the establishment. As the
final rule includes a broader set of circumstances requiring a
mandatory update, it has the potential to be slightly more costly.
Under the final rule, however, establishments will provide updates
electronically, as opposed to submitting such information to FDA using
a paper form as required by current Sec. 807.26. ERG found that the
ability to submit updated information through FURLS rather than
completing and mailing paper forms to result in a net reduction in
administrative burden and, therefore, a cost savings to establishments.
ERG did not quantify the savings, but we estimate it will negate any
cost increase from the greater likelihood of a mandatory update.
4. Requirement for Additional Device Listing Information
Under Sec. 807.25, establishments will be required to submit
additional information, including 510(k) numbers and HDE numbers among
the types of premarket submission numbers submitted to FDA for non-
exempt devices. Establishments will also submit all proprietary and
brand names under which each device is marketed. Although the Agency
already collects proprietary or brand names as part of device listings,
the device listing form specified for use under the existing regulation
has a single block of 80 characters for proprietary and brand names.
which may have been restricting the amount of information
establishments have been providing. Establishments using FURLS to list
their devices electronically have an unlimited amount of space to
provide information and could submit more data. According to the ERG
memo, electronic device listings will rarely have more than three
proprietary or brand names, so the additional information that
establishments will be providing under the final rule is limited.\6\
---------------------------------------------------------------------------
\6\ ERG memo, p. 5.
---------------------------------------------------------------------------
Under Sec. 807.25(g)(4), establishments will be required to submit
510(k) and HDE numbers for non-exempt devices as part of the listing
process. We do not attempt to quantify this very small burden, as
owners or operators need only a few minutes to retrieve this
information from readily available sources.\7\ Many establishments are
already submitting this information electronically and others have been
voluntarily submitting this information since FDA began to collect it
on a voluntary basis in 2005. The inclusion of the 510(k) number in the
device listing will result in significant benefits. Such information
would improve our postmarket surveillance efforts by permitting devices
to be tracked based on the submission number assigned to the particular
device. Absent the 510(k) number, tracking would be done by reported
product codes, which do not necessarily correspond to the product codes
under which a device was cleared. The process of having the registrant
supply the premarket submission number and FDA determine the
appropriate product code saves time and saves costs FDA had been
incurring addressing incorrectly entered product codes.
---------------------------------------------------------------------------
\7\ ERG memo, p. 6.
---------------------------------------------------------------------------
5. Changes Relating to Review and Update of Device Listings
Section 510(j)(2) of the FD&C Act, as amended by section 223 of
FDAAA, now requires device listings to be updated once each year during
the period beginning on October 1 and ending on December 31.
Previously, as reflected in the current registration and listing
regulations, registrants had to review and update their device listings
on a semiannual basis, during June and December. FDA had not strictly
enforced this requirement but did encourage establishments to update
their listings throughout the year whenever information had changed.
The required updates under this final rule are less frequent. Despite
this, there is a potential increase in cost from increased enforcement.
Any additional impact will be too small to reliably quantify.
6. Requests for a Waiver From Submitting Information Electronically
Under the final rule, parties for whom registering and listing by
electronic means is not reasonable may request a waiver from FDA.
Because one would only need to have access to a computer, Internet
access, and an email address to register and list by electronic means,
we do not anticipate many requests for waivers.
For the first few months of operation (i.e., October through
December 2007) of the Web-based system, FDA received fewer than 10
requests for waivers from the requirement to submit registration and
listing information electronically. As FDA received electronic
submissions for more than 16,000 establishments over that period, these
requests amount to about 0.06 percent of the total number of
establishments that responded.
Based on information taken from our databases as of September 2011,
FDA estimated there were 21,254 owners or operators who collectively
registered a total of 24,000 device establishments. If 0.06 percent of
the 24,000 total device establishments would request waivers from FDA,
there would be 14 requests (24,000 x 0.0006). We estimate submitting a
waiver requires an hour of time from a mid-level manager to draft,
approve, and mail a letter. At a benefit-adjusted hourly wage of $41
for a
[[Page 45935]]
regulatory affairs official, 14 waivers cost $583.\8\
---------------------------------------------------------------------------
\8\ 2010 National Industry-Specific Occupational Employment and
Wage Estimates, U.S. Department of Labor Statistics, last modified
May 17, 2011 (www.bls.gov/oes/current/naics4_339100.htm); mean
compliance officer wage rate of $31.68 for medical equipment and
supplies manufacturing industry (NAICS 339100) plus a 30-percent
increase for benefits.
---------------------------------------------------------------------------
Additional firms will enter the device industry over the next
several years and would need to list and register. Some may request
waivers, resulting in small additional costs in the future.
7. Elimination of Exemptions for Some Foreign Establishments
Under current Sec. 807.40(a), foreign establishments are not
required to comply with the registration and listing requirements if
their device enters a foreign trade zone and is re-exported from that
foreign trade zone without having entered U.S. commerce. This final
rule revises this section to eliminate the exemption.
Current Sec. 807.40(c) exempts devices imported under section
801(d)(3) of the FD&C Act (``import-for-export'' provision) from
registration and listing requirements. This final rule eliminates this
exemption; devices currently exempted will have to be listed and the
foreign establishments that manufacture these devices will have to
register with FDA. Listing a device requires approximately 2.5
hours.\9\ At $41 per hour, the cost of listing a device is $103.
---------------------------------------------------------------------------
\9\ ERG source on listing time.
---------------------------------------------------------------------------
We do not possess a precise estimate of the number of devices
affected by the loss of these exemptions. According to the databases
maintained by FDA's Division of Import Operations and Policy, 1,344
shipments of devices entered the United States under the ``import-for-
export'' provision in 2006, about 0.13 percent of device shipments.\10\
Using 1,344 as a rough estimate of the devices affected by the loss of
the ``import for export'' exemption, the cost to foreign exporters is
about $138,000 (1,344 shipments x 2.5 hours per shipment x $41/hour).
These are one-time costs, as subsequent shipments of the same device
would not require an additional registration and listing. The
continuing introduction of new devices from foreign exporters will
result in some additional costs each year. These additional annual
costs, which we do not quantify, will be a small fraction of the one-
time $138,000 cost to foreign exporters.
---------------------------------------------------------------------------
\10\ ERG memo, p. 10.
---------------------------------------------------------------------------
We do not have a reliable estimate for the number of devices and
firms affected by the loss of the exemption for devices imported into
foreign trade zones. We expect the number of affected devices and firms
to be small. We believe the overall impact on individual foreign firms
from the loss of this exemption will be very small.
The elimination of these exemptions will not be costly for domestic
device establishments. As these devices are not intended for U.S.
commerce, there will be no impact on the domestic market for these
devices. The cost per affected device will be small, so the elimination
of these exemptions will have a negligible impact on U.S. industries
doing ``import-for-export'' and operating in foreign trade zones. There
would potentially be a cost to U.S. industry if an affected foreign
establishment was actually a foreign presence of a domestic entity, but
we have no knowledge of such establishments.
8. Elimination of Registration and Listing Exemptions for Contract
Manufacturers and Sterilizers Who Do Not Commercially Distribute the
Devices
Under current Sec. 807.20(a)(2), (c)(1), and (c)(2), contract
manufacturers and contract sterilizers are exempt from registration and
listing obligations if they make or sterilize a device according to
another person's specifications for commercial distribution by the
person who developed the specifications. This final rule will eliminate
the exemption from registration and listing for contract manufacturers
and contract sterilizers who do not commercially distribute. Contract
manufacturers and contract sterilizers not currently registering will
be required to do so. Registration and listing is a recurring
obligation, so there are annual costs associated with this impact.
As of October 2007, there were 1,304 registered contract
manufacturers in our registration and listing database who had not
previously listed any products. Of these 1,304 establishments, 736 re-
registered in 2006. A small number of additional contract manufacturers
may not be in our database, but will be registering for the first time
because of the loss of an exemption. We use the 736 establishments as
our estimate for the contract manufacturers that will need to register
and initially list products.
The registration and listing database in September 2011 contained
about 121,300 listed devices and 24,000 registered establishments, or
about 5.05 devices per establishment. If the estimated 736 affected
contract manufacturers have an average of 5.05 devices, there will be
3,717 additional device listings.
Between 1999 and 2006, there was an average of 306 initial contract
manufacturer registrations each year. Assuming 306 contract
manufacturers initially register each year and there are 5.05 devices
per establishment, there will be 1,545 additional listings each year.
In the first year of our analysis, we assume 736 existing contract
manufacturers and 306 contract manufacturers initially registering for
a total of 1,042. At 5.05 devices per establishment, there would be
1,566 additional listings for a total of 5,262 the first year.\11\
---------------------------------------------------------------------------
\11\ We do not follow the assumption in the ERG memo that half
of these contract manufacturers would not register and pay user
fees.
---------------------------------------------------------------------------
There are 116 registered establishments that perform contract
sterilizations only and have no listed devices. Our databases also
include 114 contract sterilizers associated with 533 device listings,
an average of 4.68 listings per establishment. We assume that the 116
contract sterilizers with no listed devices are establishments
currently not required to list but will be required to list under the
final rule. Assuming these establishments also have an average of 4.68
listings, there will be 543 additional listings from the loss of the
exemption for contract sterilizers.
We assume registration and listing requires 2.5 hours of time per
listed device each year.\12\ At a labor rate of $41 per hour, including
benefits, registration and listing costs $103 per device or $520 per
contract manufacturing establishment ($103 per listing x 5.05 listings)
and $482 per contract sterilizing establishment ($103 per listing x
4.68 listings). Across all affected contract manufacturers the cost
will be a recurring $539,000 ($41 per hour x 2.5 hours x 5,262
listings). For contract sterilizers, the cost will be $56,000 ($41 per
hour x 2.5 hours x 543 listings). Thus, the impact on contract
manufacturers and contract sterilizers will be an annual $595,000
($539,000 + $56,000). We may not be aware of some contract sterilizers
that have never registered, but there are likely few such firms and do
not account for them in our analysis.
---------------------------------------------------------------------------
\12\ ERG memo, p. 9.
---------------------------------------------------------------------------
The loss of the exemption for contract manufacturers and
sterilizers who do not commercially distribute the devices will not
only result in social economic costs, but will also result in transfers
associated with the payment of user fees. Contract manufacturers and
sterilizers that are required to register
[[Page 45936]]
will be required to pay user fees. According to section 212 of FDAAA,
the FY 2012 establishment registration fee is $2,029. At that rate, we
estimate FY 2012 fees of $2.35 million, $2.11 million paid by the 1,042
contract manufacturers and $235,000 paid by the 116 contract
sterilizers.
Table 1 of this document summarizes the projected quantified
impacts of this final rule. The total annual costs are $340,000.
Foreign establishments will face an additional annual burden of
$138,000 due to the loss of the exemptions from registration and
listing requirements relating to devices entering a foreign trade zone
that are later re-exported without having entered U.S. commerce and
devices that are imported into the United States under section
801(d)(3) of the FD&C Act. There would also be a transfer of $2.14
million in additional user fees paid by contract manufacturers and
sterilizers.
Table 1--Projected Impacts of the Final Rule
----------------------------------------------------------------------------------------------------------------
No. of affected
Establishment category establishments/ Incremental time Cost per Total annual cost \3\
devices hour \1\
----------------------------------------------------------------------------------------------------------------
Requests for a Waiver from 14 establishments 1 hr............. $41 $583
Submitting Information
Electronically.
Foreign establishments none \2\......... 2.5 hrs.......... 41 0 \2\
shipping to United States
under import-for-export and
to foreign trade zones.
Elimination of Exemptions for 5,262 devices, 2.5 hrs.......... 41 539,000
Contract Manufacturers. 1,042
establishments.
Elimination of Exemptions for 543 devices, 116 2.5 hrs.......... 41 56,000
Contract Sterilizers. establishments.
All other..................... negligible....... ................. ........... negligible \3\
---------------------------------------------------------------------------------
Total..................... 1,172 ................. ........... 598,000
establishments
5,805 devices.
----------------------------------------------------------------------------------------------------------------
\1\ Average hourly wage for medical equipment and supplies compliance officer, adjusted for benefits.
\2\ Provision would not be expected to affect U.S. establishments. An estimated 1,344 foreign establishments
would face additional annual costs of $138,000.
\3\ Estimated incremental time costs are offset by incremental time savings.
Table 2--Economic Transfers Associated with the Final Rule
----------------------------------------------------------------------------------------------------------------
Cost per
From To Description entity Total cost
----------------------------------------------------------------------------------------------------------------
1,042 Contract Manufacturers and U.S. Government.... Establishment $2,029 $2.35 million.
116 Contract Sterilizers. Registration Fees.
----------------------------------------------------------------------------------------------------------------
The final rule will result in benefits associated with an
electronic registration and listing database that would provide more
up-to-date and complete information. The electronic registration and
listing database system could also support future medical and health
information technology initiatives. The final rule will increase the
efficiency of the registration and listing process by eliminating all
or nearly all paper submissions. With registration and listing in an
electronic format, we are able to review the submitted information more
quickly and can contact submitting firms immediately through email if
any additional information is needed. In addition, a more accurate and
more complete database of registered establishments and listed devices
benefits patient safety by facilitating timely notification of recalls
of certain unsafe devices and prompt identification of the affected
manufacturers.
Although the scope of the final rule does not extend beyond
registration and listing, the resulting high-quality, electronic
database will facilitate future uses of technology for the public
benefit. A current electronic database of device information could, for
example, facilitate the development of future devices utilizing
wireless connectivity and the interoperation of such devices with
hospital information systems, or with handheld personal digital
assistant (PDA)-type clients used by health care providers or those
managing hospital inventories.
Additionally, having a paper-based registration and listing system
is inconsistent with section 510(p) of the FD&C Act, as amended by
section 224 of FDAAA, and might deter the medical device industry and
healthcare providers from investing in new initiatives that would make
use of electronic device listing and establishment registration data.
E. Regulatory Flexibility Act
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. The impact of this final rule is almost entirely
attributable to the requirement that contract manufacturers and
contract sterilizers register and list. We have estimated the impacts
on small entities and find that the costs associated with registering
and listing will not be a significant burden for even the smallest of
contract manufacturers and contract sterilizers. Moreover, failing to
remove this exemption for contract manufacturers and sterilizers would
reduce the benefits of this final rule. These benefits include
improving the quality and timeliness of information, facilitating
device recalls, complementing postmarket surveillance programs,
ensuring the safety of imported devices, and improving the scheduling
and planning of inspections. Requiring contract manufacturers and
sterilizers to register and list allows for the appropriate oversight
of these types of facilities. For other elements of this final rule,
the costs per entity are very small and we do not believe that this
final rule will have a significant economic impact on a substantial
number of small entities.
As described earlier in this preamble, this final rule will revise
the Agency's regulations at part 807 to make them consistent with the
requirement under FDAAA that the Agency shift to an
[[Page 45937]]
electronic registration and listing format. The incremental costs to
establishments making this switch to electronic registration and
listing are so small as to be difficult to quantify. Certain elements
of the final rule may be costly to some entities, but the actual
incremental costs are estimated to be extremely small. We estimate the
cost of submitting a waiver claiming electronic listing and
registration to be $41. The cost of registering and listing a device
because of the loss of the exemptions from registration and listing
requirements for devices imported into foreign trade zones or imported
under section 801(d)(3) of the FD&C Act is not expected to have an
effect on domestic establishments. Other elements of the final rule
involve the submission of information not currently required but
readily available and the estimated cost of compliance will be so small
as to be difficult to estimate.
Contract manufacturers and contract sterilizers who do not
commercially distribute the devices they make or sterilize will be
faced with a new requirement to register and list. We do not know how
many of the affected contract manufacturers and contract sterilizers
would be categorized as small. As shown in table 1 of this document, we
estimate 1,042 affected contract manufacturers and 116 affected
contract sterilizers. Our internal databases include some contract
manufacturers and sterilizers that have in the past voluntarily
registered. A review of the contract sterilizers in this database
indicate many are described in external databases as being part of
NAICS code 339113 (Surgical Appliance and Supplies Manufacturing).
Because of the specific expertise, capital requirements, and economies
of scale associated with contract sterilization, we expect contract
sterilizers will have more employees and more revenues per employee
than would a typical establishment in this class. Medical device
contract manufacturers fit in NAICS code 339112 (Surgical and Medical
Instrument Manufacturing). For both of these industry classifications,
the U.S. Small Business Administration has defined a small business as
one with 500 or fewer employees.\13\
---------------------------------------------------------------------------
\13\ U. S. Small Business Administration, ``Table of Small
Business Size Standards Matched to North American Industry
Classification System Codes,'' March 26, 2012. http://www.sba.gov/sites/default/files/files/Size_Standards_Table.pdf.
---------------------------------------------------------------------------
According to the U.S. Census there are 1,340 establishments in
class 339112 with 1,293 of them (96 percent) having fewer than 500
employees.\14\ Census information on class 339113 lists 2,219
establishments, with 2,189 of them (99 percent) having fewer than 500
employees.\15\ Applying these profiles to our estimated contract
manufacturers and contract sterilizers, there would be 1,000 small
affected contract manufacturers (96 percent of 1,042) and 116 small
affected contract sterilizers (99 percent of 118).
---------------------------------------------------------------------------
\14\ U.S. Census Bureau, 2007 Economic Census, ``Surgical and
Medical Instrument Manufacturing,'' released November 16, 2010,
http://factfinder.census.gov/servlet/IBQTable?_bm=y&-ds_name=EC0731SG3&-ib_type=NAICS2007&-NAICS2007=339112.
\15\ U.S. Census Bureau, 2007 Economic Census, ``Surgical
Appliance and Supplies Manufacturing,'' released November 16, 2010,
http://factfinder.census.gov/servlet/IBQTable?_bm=y&-ds_name=EC0731SG3&-ib_type=NAICS2007&-NAICS2007=339113.
---------------------------------------------------------------------------
For class 339112, we consider the establishment group of
establishments with 10 to 19 employees, the smallest group for which
data are provided. According to Census data, there are 183
establishments with a total value of shipments of $468 million. The
average value of shipments is $2.6 million. As discussed in section V.D
of this document, establishment registration user fees are $2,029 for
FY 2012, and as shown in table 1 of this document, the estimated annual
burden of listing a device is 2.5 hours at $41 per hour, or $103. A
small contract manufacturer with a single listed device would face an
annual burden of $2,029 plus $103, or $2,132, which is 0.08 percent of
annual revenues.
Table 3--Small Entity Characteristics and the Impact of the Final Rule
------------------------------------------------------------------------
------------------------------------------------------------------------
Surgical and Medical
Instrument Manufacturing
(NAICS 339112)
------------------------------------------------------------------------
Number of Employees........................... 10 to 19 20 to 49
Total Value of Shipments ($1000).............. 468,343 1,293,992
Number of Establishments...................... 183 183
Average Value of Shipments ($)................ 2,559,000 7,071,000
Annual Costs as a Percentage of the Average 0.08% 0.03%
Value of Shipments...........................
------------------------------------------------------------------------
For class 339113, considering establishments with 10 to 19
employees, the smallest group for which data are provided, there are
302 establishments a total value of shipments of approximately $798
million. The average value of shipments is $2.6 million. Contract
sterilizers will face an annual establishment fee of $2,029 plus a cost
of $103 per listed device. A small contract sterilizer with 2 listed
devices will face an annual burden of $2,029 plus $206, $2,235. This
amount is equal to 0.17 percent of annual revenues, well below typical
thresholds cited for significant impacts.
Table 4--Small Entity Characteristics and the Impact of the Final Rule
------------------------------------------------------------------------
------------------------------------------------------------------------
Surgical Appliance and
Supplies Manufacturing
(NAICS 339113)
------------------------------------------------------------------------
Number of Employees........................... 10 to 19 20 to 49
Total Value of Shipments ($1000).............. 797,774 1,686,427
Number of Establishments...................... 302 324
Average Value of Shipments ($)................ 2,642,000 5,205,000
Annual Costs as a Percentage of the Average 0.08% 0.04%
Value of Shipments...........................
------------------------------------------------------------------------
A $41 burden associated with a waiver request is be about 0.01
percent of revenues for a small entity with revenues in the hundreds of
thousands of dollars. As discussed earlier in section V.D of this
document, other impacts associated with this final rule are all
extremely small. We therefore conclude that the final rule will not
have a significant impact on a substantial number of small entities.
Affected entities currently possess the skills required to comply with
the provisions of this final rule.
FDA considered regulatory alternatives such as not regulating and
not requiring registration and listing by contract manufacturers and
contract sterilizers who do not commercially distribute devices. As
explained earlier in this preamble, the electronic submission of
information is mandated under FDAAA. The benefits associated with
Agency oversight of contract manufacturers and contract sterilizers
justify the estimated costs of requiring that they register and list.
VI. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The title,
description, and respondent description of the
[[Page 45938]]
information collection provisions are shown in the following paragraphs
with an estimate of the annual reporting and recordkeeping burden.
Included in the estimate is the time for reviewing instructions,
searching existing data sources, gathering and maintaining the data
needed, and completing and reviewing each collection of information.
Title: Implementation Electronic Submission of Medical Device
Registration and Listing (OMB Control No. 0910-0625)--Revision
Description: In accordance with the collection of information
entitled ``Electronic Submission of Medical Device Registration and
Listing,'' medical device establishment owners and operators will be
required to electronically submit establishment registration and device
listing information.
Section 510(c) of the FD&C Act requires owners or operators of
domestic establishments upon first engaging in the ``manufacture,
preparation, propagation, compounding, or processing'' of a device or
devices in those establishments to immediately register their name and
place of business and such establishment. Section 510(a)(1) of the FD&C
Act defines the term ``manufacture, preparation, propagation,
compounding, or processing'' to include ``repackaging or otherwise
changing the container, wrapper, or labeling of any * * * device
package in furtherance of the distribution of the * * * device from the
original place of manufacture to the person who makes final delivery or
sale to the ultimate consumer or user.''
Section 510(a)(2) of the FD&C Act mandates that the term ``name''
include, among other things, the name of each partner of a partnership,
and the name of each corporate officer and director of a corporation.
An owner or operator of a registered establishment must also
immediately register any additional establishment that he owns or
operates in any State and in which he begins the ``manufacture,
preparation, propagation, compounding, or processing'' of a device
(section 510(d) of the FD&C Act). An owner or operator of any
establishment that engages in these activities must also re-register
its establishment once each year during the period beginning on October
1 and ending on December 31 of each year (section 510(b) of the FD&C
Act, as amended by FDAAA).
Section 510(i) of the FD&C Act contains certain registration
requirements pertaining to foreign establishments (e.g., submission of
the name of each importer of the establishment's device in the United
States that is known to the establishment, submission of the name of
each person who imports or offers for import the establishment's device
to the United States for purposes of importation). Section 510(g) of
the FD&C Act provides for certain exemptions from the registration
requirements. In addition, section 510(p) of the FD&C Act, as amended
by FDAAA, requires the electronic submission of device registration and
listing information unless the Secretary grants a request for a waiver
because use of electronic means is not reasonable for the person
requesting the waiver.
Section 510(j)(1) of the FD&C Act requires that every person who
registers must, at the time of registration, submit a list of all
devices that are being manufactured, prepared, propagated, compounded,
or processed by him or her for commercial distribution which have not
been previously listed by him or her. This information must be
submitted in the form and manner prescribed by the Secretary (section
510(j)(1) of the FD&C Act). Prior to FDAAA, section 510(j)(2) of the
FD&C Act required certain changes in listing information to be reported
every June and December, including any material changes in information
previously submitted under the listing provisions. This information
must now be provided only once each year during the period beginning on
October 1 and ending on December 31.
Section 510(e) of the FD&C Act permits the Secretary to prescribe a
uniform system for the identification of devices intended for human use
and may require that persons who are required to list such devices
under section 510(j) shall list such devices in accordance with such a
system. The disclosure provision in section 510(f) of the FD&C Act
requires the Secretary to make available for inspection any
registration filed under section 510. Section 510(f) also provides that
certain listing information must be exempt from disclosure unless the
Secretary finds that such exemption would be inconsistent with
protection of the public health.
Complete and accurate registration and listing information is
necessary to accomplish a number of statutory and regulatory
objectives, such as: Identification of establishments producing
marketed medical devices, identification of establishments producing a
specific device when that device is in short supply or is needed for
national emergency, facilitation of recalls for devices marketed by
owners and operators of device establishments, identification and
cataloguing of marketed devices, administering postmarketing
surveillance programs for devices; identification of devices marketed
in violation of the law; identification and control of devices imported
into the country from foreign establishments; and scheduling and
planning inspections of registered establishments under section 704 of
the FD&C Act.
The electronic collection of establishment registration and device
listing information from medical device establishment owners and
operators also furthers the purpose of several statutes, including: The
FDAAA, the Bioterrorism Act, MDUFMA, and GPEA.
Description of Respondents: Owners or operators of establishments
that engage in the manufacturing, preparation, propagation,
compounding, or processing of a device or devices must register their
establishments and submit listing information for each of their devices
in commercial distribution. Notwithstanding certain exceptions, foreign
device establishments that manufacture, prepare, propagate, compound,
or process a device that is imported or offered for import into the
United States must also comply with the registration and listing
requirements.
The total annual estimated burden imposed by this collection of
information is 99,470 hours annually.
FDA estimates the burden of this collection of information as
follows:
Table 5--Estimated Annual Reporting Burden\1\
----------------------------------------------------------------------------------------------------------------
Annual
FDA Form Number of frequency Total Hours per
21 CFR Section number respondents per annual response Total hours
response responses
----------------------------------------------------------------------------------------------------------------
807.20(a)(5) \2\ Submittal of 3673 8,594 1 8,594 1.75 15,040
Manufacturer Information by
Initial Importers.............
[[Page 45939]]
807.20(a)(5)\3\ Submittal of 3673 8,594 3 25,782 0.1 2,578
Manufacturer Information by
Initial Importers.............
807.21(a) \3\ Creation of 3673 3,559 1 3,559 .5 1,780
Electronic System Account.....
807.21(b) \2\ Annual Request ........... 14 1 14 1 14
for Waiver From Electronic
Registration & Listing........
807.21(b) \3\ Initial Request ........... 4 1 4 1 4
for Waiver From Electronic
Registration & Listing........
807.22(a) \3\ Initial 3673 3,539 1 3,539 0.5 1,770
Registration & Listing........
807.22(b)(1) \3\ Annual 3673 20,335 1 20,335 0.75 15,266
Registration..................
807.22(b)(2) \3\ Other Updates 3673 4,176 1 4,176 0.5 2,088
of Registration...............
807.22(b)(3) \3\ Annual Update 3673 19,875 1 19,875 1 19,875
of Listing Information........
807.26(e) \3\ Labeling & ........... 71 1 71 1 71
Advertisement Submitted at FDA
Request.......................
807.34(a) \2\ Initial ........... 14 1 14 1 14
Registration & Listing When
Electronic Filing Waiver
Granted.......................
807.34(a) \3\ Annual ........... 4 1 4 1 4
Registration & Listing When
Electronic Filing Waiver
Granted.......................
807.40(b)(2) \3\ Annual Update 3673 1,615 1 1,615 0.5 808
of U.S. Agent Information.....
807.40(b)(3) \3\ U.S. Agent 3673 1,535 1 1,535 0.25 384
Responses to FDA Requests for
Information...................
807.41(a) \3\ Identification of 3673 10,329 1 10,329 0.5 5,165
Initial Importers by Foreign
Establishments................
807.41(b) \3\ Identification of 3673 10,329 1 10,329 0.5 5,165
Other Parties That Facilitate
Import by Foreign
Establishments................
--------------------------------------------------------------------------------
Total One Time Burden...... ........... .............. ........... ........... ........... 15,068
--------------------------------------------------------------------------------
Total Recurring Burden..... ........... .............. ........... ........... ........... 54,958
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ One Time Burden.
\3\ Recurring Burden.
Table 6--Estimated Annual Recordkeeping Burden \1\
----------------------------------------------------------------------------------------------------------------
Annual Total
21 CFR Section No. of frequency per annual Hours per Total hours
respondents recordkeeper records record
----------------------------------------------------------------------------------------------------------------
807.25(d) \2\ List of Officers, Directors 23,806 1 23,806 .25 5,952
& Partners..............................
807.26 \2\ Labeling & Advertise-ments 11,746 4 46,984 .5 23,492
Available for Review....................
----------------------------------------------------------------------
Total................................ .............. .............. ........... ........... 29,444
----------------------------------------------------------------------------------------------------------------
\1\ There are no capital costs or operating and maintenance costs associated with this collection of
information.
\2\ Recurring burden.
The reporting and recordkeeping estimated burden for electronic
registration and listing under OMB number 0910-0625 for the proposed
rule is larger for reporting and smaller for recordkeeping than the
burden estimated for the final rule (7,911 and 11,977 smaller,
respectively) because of more accurate re-estimates using information
from our FURLS database.
The currently approved reporting and recordkeeping burden for
electronic registration and listing under OMB number 0910-0625 is
71,319. The estimated reporting and recordkeeping burden for electronic
registration and listing under the rule is 99,470 hours, an increase of
28,151 hours. This increase is due to the incremental increase of
respondents no longer exempt from these requirements weighed against
the change in reporting requirements for all owner operators and the
decrease in the overall number of device establishments that have
registered since OMB approved the collection of information under
control number 0910-0625.
Burden estimates are based on recent experience with the existing
medical device registration and listing program and the economic
analysis provided by ERG. The changes to the actual data collected are
very minor, with one exception. We are assuming that it will take
approximately the same amount of time to enter the data online using
FURLS as it does to use the portable document format (PDF)-enabled
forms that had been used for initial establishment registration prior
to FURLS becoming operational in October 2007. Any additional burden
associated with creating and using the Web-based system accounts (as
shown in table 3 of this document under Sec. 807.21(a)) should be
offset by the elimination of the need to re-enter identifying
information concerning the establishment or product every time
registration or listing information is updated, which was the case when
updating such information using the PDF-enabled forms.
The recurring burden for the new data collection under Sec. 807.41
(import-related information provided by foreign companies exporting to
the United States) was estimated based on the ERG
[[Page 45940]]
memo. This report stated that foreign establishments would typically be
identifying one or two importers and one or two persons who import or
offer for import with readily available contact information.
The estimates for creation of new user accounts under Sec.
807.21(a) are based on the current number of owners or operators, and
experience in account creation using the existing FURLS for Food
Facility Registration. The estimates for the recurring years assume a
similar increase in the number of new owner or operator numbers as were
created in FY 2006.
The estimate for Sec. 807.25(d) in table 5 of this document
(recordkeeping burden) reflects the requirement that owners or
operators keep a list of officers, directors, and partners for each
establishment. Owners or operators will need to provide this
information only when requested by FDA. However, it is assumed that
some effort will need to be expended to keep such lists current.
The requirements shown in table 5 for Sec. 807.26 (renumbered from
Sec. 807.31), have not changed based on this revision to the
registration and listing regulations. They reflect other recordkeeping
requirements for devices listed with FDA, and the requirement to
provide these records when requested by FDA. They are based on
experience FDA has had with the existing regulation.
This final rule refers to previously approved collections of
information found in FDA regulations. These collections of information
are subject to review by the Office of Management and Budget (OMB)
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The
collections of information in 21 CFR 807.35(b) refer to currently
approved collections in 21 CFR part 607 OMB control number 0910-0052
and 21 CFR part 207 OMB control number 0910-0045. This rule will not
impact the burden in 0910-0052 and 0910-0045 which are already
accounted for in those information collections.
Before the effective date of this final rule, FDA will publish a
notice in the Federal Register announcing OMB's decision to approve,
modify, or disapprove the information collection provisions in this
final rule. An Agency may not conduct or sponsor, and a person is not
required to respond to, a collection of information unless it displays
a currently valid OMB control number.
VII. Environmental Impact
The Agency has determined under 21 CFR 25.30(h) that this action is
of a type that does not individually or cumulatively have a significant
effect on the human environment. Therefore, neither an environmental
assessment nor an environmental impact statement is required.
VIII. Federalism
FDA has analyzed this final rule in accordance with the principles
set forth in Executive Order 13132. FDA has determined that the rule
does not contain policies that have substantial direct effects on the
States, on the relationship between the National Government and the
States, or on the distribution of power and responsibilities among the
various levels of government. Accordingly, the Agency has concluded
that the rule does not contain policies that have federalism
implications as defined in the Executive order and, consequently, a
federalism summary impact statement is not required.
IX. References
The following references have been placed on display in the
Division of Dockets Management (see ADDRESSES), and may be seen by
interested persons between 9 a.m. and 4 p.m., Monday through Friday.
FDA has verified the Web site addresses, but we are not responsible for
any subsequent changes to the Web sites after this document publishes
in the Federal Register.
1. Bureau of Labor Statistics, May 2008, National Industry-
Specific Occupational Employment and Wage Estimates, NAICS 339100--
Medical Equipment and Supplies Manufacturing, Occupation (SOC code):
(131041) http://www.bls.gov/oes/current/naics4_339100.htm.
2. Eastern Research Group memorandum from Cal Franz, Derek
Singer, and John Eyraud to FDA, September 15, 2008.
3. Office of Management and Budget, Circular A-4, Regulatory
Analysis, Washington, DC, 2003, http://www.whitehouse.gov/omb/circulars_a004_a-4/Circular A-4 The White House.
List of Subjects in 21 CFR Part 807
Confidential business information, Imports, Medical devices,
Reporting and Recordkeeping requirements.
Therefore, under the Federal Food, Drug, and Cosmetic Act, and
under authority delegated to the Commissioner of Food and Drugs, 21 CFR
part 807 is amended as follows:
PART 807--ESTABLISHMENT REGISTRATION AND DEVICE LISTING FOR
MANUFACTURERS AND INITIAL IMPORTERS OF DEVICES
0
1. The authority citation for 21 CFR part 807 continues to read as
follows:
Authority: 21 U.S.C. 321, 331, 351, 352, 360, 360c, 360e, 360i,
360j, 371, 374, 381, 393; 42 U.S.C. 264, 271.
0
2. Amend Sec. 807.3 by:
0
a. Adding ``and'' at the end of paragraph (e)(3);
0
b. Removing ``;and'' at the end of paragraph (e)(4) and adding a period
in its place;
0
c. Removing paragraph (e)(5);
0
d. Revising paragraph (i);
0
e. Redesignating paragraphs (k) through (s) as paragraphs (l) through
(t), respectively; and
0
f. Adding a new paragraph (k) and adding paragraphs (u) through (y).
The revisions and additions read as follows:
Sec. 807.3 Definitions.
* * * * *
(i) Restricted device means a device for which a requirement
restricting sale, distribution, or use has been established by a
regulation issued under section 520(e) of the act, by order as a
condition of premarket approval under section 515(d)(1)(B)(ii) of the
act, or by a performance standard issued in accordance with sections
514(a)(2)(B)(v) and 514(b) of the act.
* * * * *
(k) Product code means the code used by FDA to identify the generic
category of a device.
* * * * *
(u) Fiscal year means the FDA fiscal year, which runs from October
1 through September 30.
(v) FURLS means the Food and Drug Administration's Unified
Registration and Listing System,
(w) FDA premarket submission number means the number assigned by
FDA to a premarket device submission, such as a Premarket Approval
Application (PMA); Humanitarian Device Exemption (HDE); New Drug
Application (NDA); Biologics License Application (BLA); de novo
classification petition; or Premarket Notification (510(k)).
(x) Importer means, for purposes of this part, a company or
individual in the United States that is an owner, consignee, or
recipient, even if not the initial owner, consignee, or recipient, of
the foreign establishment's device that is imported into the United
States. An importer does not include the consumer or patient who
ultimately purchases, receives, or uses the device, unless the foreign
establishment ships the device directly to the consumer or patient.
(y) Person who imports or offers for import means, for purposes of
this part, an agent, broker, or other entity, other than a carrier,
that the foreign establishment uses to facilitate the
[[Page 45941]]
import of its device into the United States.
0
3. Revise Sec. 807.20 to read as follows:
Sec. 807.20 Who must register and submit a device list?
(a) An owner or operator of an establishment not exempt under
section 510(g) of the Federal Food, Drug, and Cosmetic Act or subpart D
of this part who is engaged in the manufacture, preparation,
propagation, compounding, assembly, or processing of a device intended
for human use shall register and submit listing information for those
devices in commercial distribution, except that registration and
listing information may be submitted by the parent, subsidiary, or
affiliate company for all the domestic or foreign establishments under
the control of one of these organizations when operations are conducted
at more than one establishment and there exists joint ownership and
control among all the establishments. The term ``device'' includes all
in vitro diagnostic products and in vitro diagnostic biological
products not subject to licensing under section 351 of the Public
Health Service Act. An owner or operator of an establishment located in
any State as defined in section 201(a)(1) of the Federal Food, Drug,
and Cosmetic Act shall register its name, places of business, and all
establishments and list the devices whether or not the output of the
establishments or any particular device so listed enters interstate
commerce. The registration and listing requirements shall pertain to
any person who is engaged in the manufacture, preparation, propagation,
compounding, assembly, or processing of a device intended for human
use, including any person who:
(1) Initiates or develops specifications for a device that is to be
manufactured by a second party;
(2) Sterilizes or otherwise makes a device for or on behalf of a
specifications developer or any other person;
(3) Repackages or relabels a device;
(4) Reprocesses a single use device that has previously been used
on a patient;
(5) Acts as an initial importer as defined in Sec. 807.3(g),
except that initial importers may fulfill their listing obligation for
any device for which they did not initiate or develop the
specifications for the device or repackage or relabel the device by
submitting the name and address of the manufacturer. Initial importers
shall also be prepared to submit, when requested by FDA, the
proprietary name, if any, and the common or usual name of each device
for which they are the initial importer;
(6) Manufactures components or accessories that are ready to be
used for any intended health-related purpose and are packaged or
labeled for commercial distribution for such health-related purpose,
e.g. blood filters, hemodialysis tubing, or devices which of necessity
must be further processed by a licensed practitioner or other qualified
person to meet the needs of a particular patient, e.g., a manufacturer
of ophthalmic lens blanks.
(b) Registration or listing does not constitute an admission or
agreement or determination that a product is a device within the
meaning of section 201(h) of the Federal Food, Drug, and Cosmetic Act.
(c) Registration and listing requirements shall not pertain to any
person who acts as a wholesale distributor, as defined in Sec.
807.3(t), and who does not manufacture, repackage, process, or relabel
a device.
(d) Owners and operators of establishments or persons engaged in
the recovery, screening, testing, processing, storage, or distribution
of human cells, tissues, and cellular and tissue-based products, as
defined in Sec. 1271.3(d) of this chapter, that are regulated under
the Federal Food, Drug, and Cosmetic Act must register and list those
human cells, tissues, and cellular and tissue-based products with the
Center for Biologics Evaluation and Research on Form FDA 3356 following
the procedures set out in subpart B of part 1271 of this chapter,
instead of the procedures for registration and listing contained in
this part, except that the additional listing information requirements
of Sec. 807.26 remain applicable.
(e) Owners and operators of establishments that manufacture devices
licensed under section 351 of the Public Health Service Act as well as
licensed biological products used in the manufacture of a licensed
device must register and list following the procedures set out in part
607 of this chapter, instead of the procedures for registration and
listing contained in this part.
Sec. 807.22 [Removed]
0
4. Remove Sec. 807.22.
Sec. 807.21 [Redesignated as Sec. 807.22]
0
5. Redesignate Sec. 807.21 as Sec. 807.22.
0
6. Add new Sec. 807.21 to subpart B to read as follows:
Sec. 807.21 How to register establishments and list devices.
(a) Owners or operators of establishments that are subject to the
registration and listing requirements of this part must provide the
following information to us using our electronic device registration
and listing system, except as provided in paragraphs (b), (c), and (d)
of this section:
(1) Initial establishment registration information as required by
Sec. Sec. 807.22(a) and 807.25;
(2) Updates to registration information as required by Sec. Sec.
807.22(b) and 807.25;
(3) Initial device listing information as required by Sec. Sec.
807.22(a), 807.25, and 807.28;
(4) Updates to device listing information as required by Sec. Sec.
807.22(b), 807.25, and 807.28, including updates to reflect the
discontinuance or resumption of the commercial distribution of a
previously-listed device as specified at paragraphs (d) and (e) of
Sec. 807.28.
(b) If the information under Sec. 807.21(a) cannot be submitted
electronically, a waiver may be requested. Waivers will be granted only
if use of electronic means is not reasonable for the person requesting
the waiver. To request a waiver, applicants must send a letter to the
Office of Compliance, Center for Devices and Radiological Health, Food
and Drug Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 2621,
Silver Spring, MD 20993-0002, that includes the following information:
(1) The name and address of the device establishment(s) to be
registered, a contact person for the owner or operator of the
establishment, and the telephone number at which that person can be
reached. If the establishment has already registered in the past, the
letter should also include the owner or operator number, registration
number, and any listing numbers previously assigned by FDA for devices
manufactured at that establishment.
(2) Information about whether the company is an initial importer as
defined in Sec. 807.3(g) and, if so, whether it also conducts any
other activities or operations relating to devices.
(3) A statement that use of the Internet is not reasonable for the
person requesting the waiver, and an explanation of why such use is not
reasonable. The statement must be signed by the owner or operator of
the establishment, or by a person employed by the owner or operator who
is authorized to make the declaration on behalf of the owner or
operator.
(c) Those owners or operators who have obtained a waiver from
filing
[[Page 45942]]
registration and listing information electronically should refer to
Sec. 807.34 for information on how to submit such information by
postal mail.
(d) When additional device listing information (e.g., copies of
labeling or advertisements) is requested by FDA as described at Sec.
807.26(e), such information may be submitted by postal mail or
electronically by email, but will not be submitted using the FDA
electronic device registration and listing system.
0
7. Revise newly redesignated Sec. 807.22 to read as follows:
Sec. 807.22 Times for establishment registration and device listing.
(a) Initial registration and listing. An owner or operator of an
establishment who has not previously entered into an operation
described in Sec. 807.20(a) shall register within 30 days after
entering into such an operation and submit device listing information
at that time.
(b) Registration and listing updates. Owners or operators shall
review and update all of their establishment registration and device
listing information that is on file at FDA, documenting any changes
that were not previously reported as follows:
(1) Annual registration for each fiscal year is required for all
establishments. Annual registration shall take place during the period
beginning on October 1 and ending on December 31 of each fiscal year;
(2) Updates to the registration information as described in Sec.
807.25(b) shall be made within 30 days of any change to such
information;
(3) Every fiscal year, during the period beginning on October 1 and
ending on December 31, owners or operators shall review and update all
of their device listing information that is on file at FDA, reporting
any changes or deletions to listings and any new listings that were not
previously reported. The accuracy of all information on file must be
confirmed each year regardless of whether any changes were made to the
owner or operator's list of devices; and
(4) Changes to listing information may also be made at other times,
such as when a device is introduced into commercial distribution, when
a change is made to a previously-listed device, or when a previously-
listed device is removed from commercial distribution.
(c) Failure to submit required information. Failure to submit any
of the required information on time, as specified in paragraphs (a) and
(b) of this section, will put the establishment in a ``failed to
register'' or ``failed to list'' status as applicable. The
establishment will not be considered active and the establishment
registration and device listing information may not appear on the FDA
Web site until such time as the owner or operator submits and FDA
processes the required information.
0
8. Revise Sec. 807.25 to read as follows:
Sec. 807.25 Information required for device establishment
registration and device listing.
(a) All owners or operators that are subject to the registration
and listing requirements of this part shall provide such information to
us by using the FDA electronic device registration and listing system,
unless granted a waiver from electronic submission in accordance with
Sec. 807.21(b). Electronic submissions of registration and listing
information must comply with part 11 of this chapter, except for the
requirements in Sec. 11.10(b), (c), and (e), and the corresponding
requirements in Sec. 11.30 of this chapter. Those owners or operators
granted a waiver from electronic submission should refer to paragraphs
(c) and (g) of this section and Sec. 807.34 for instructions on how to
submit device registration and listing information.
(b) Registration information required to be submitted includes: The
name and mailing address of the device establishment; the Web site
address of the device establishment, if any; the name, address, phone
number, fax number, and email address of the owner or operator; the
name, address, phone number, fax number, and email address of the
establishment's official correspondent; and all trade names used by the
establishment.
(c) Owners or operators who have been granted a waiver from
electronic filing must submit the establishment registration
information described in paragraph (b) of this section, except for the
Web site and email address information, in paper form using the
procedures set forth in Sec. 807.34.
(d) Each owner or operator is required to maintain a listing of all
officers, directors, and partners for each establishment registered by
the owner or operator and to furnish this information to FDA upon
request.
(e) For each establishment, an official correspondent must be
designated by the owner or operator to serve as a point of contact with
FDA on matters relating to the registration of device establishments
and the listing of device products. Each owner or operator shall also
provide FDA with the name of a contact person at the owner or
operator's offices who will be responsible for identifying the official
correspondent for each establishment. The owner or operator contact
person will be the official correspondent in the event no one else has
been properly designated. The official correspondent is responsible
for:
(1) Providing FDA with all required registration and listing
information electronically unless a waiver from electronic submission
has been granted in accordance with Sec. 807.21(b);
(2) Receiving all correspondence from FDA concerning registration
and listing;
(3) Supplying, when requested by FDA, the names of all officers,
directors, and partners; and
(4) Receiving communications from FDA by email, or by postal mail
if the owner or operator has been granted a waiver from the requirement
to file registration and listing information electronically.
(f) The designation of an official correspondent does not in any
manner affect the liability of the owner or operator of the
establishment or any other individual under section 301(p) or any other
provision of the Federal Food, Drug, and Cosmetic Act.
(g) Device listing information must be submitted to FDA
electronically unless a waiver from electronic submission has been
granted in accordance with Sec. 807.21(b). Owners or operators who
have been granted a waiver must submit the required device listing
information, including information required by this paragraph, Sec.
807.28, and any listing information requested by FDA under Sec.
807.26(e), in paper form using the procedures set forth in Sec.
807.34. The information required for each device listed includes:
(1) The current registration number and name of each establishment
under the ownership and control of the owner or operator where the
device is manufactured, repackaged, relabeled, or otherwise processed,
or where specifications are developed.
(2) The product code for each device that is exempt from premarket
notification and approval or which was in commercial distribution prior
to May 28, 1976.
(3) The proprietary or brand name(s) under which each device is
marketed.
(4) The FDA-assigned premarket submission number of the approved
application, cleared premarket notification, granted de novo
classification petition, or approved humanitarian device exemption for
each device listed that is subject to sections 505, 510(k), 513(f)(2),
515, or 520(m) of the Federal Food, Drug, and Cosmetic Act, which
includes devices that are not exempt from premarket notification and
approval.
(5) Each activity or process that is conducted on or done to the
device at
[[Page 45943]]
each establishment, such as manufacturing, repacking, relabeling,
developing specifications, remanufacturing, single-use device
reprocessing, contract manufacturing, contract sterilizing, or
manufacturing for export only.
Sec. 807.26 [Removed and Reserved]
0
9. Remove and reserve Sec. 807.26.
Sec. 807.31 [Redesignated as Sec. 807.26]
0
10. Redesignate Sec. 807.31 as Sec. 807.26.
0
11. Amend newly redesignated Sec. 807.26 by adding paragraph (f) to
read as follows:
Sec. 807.26 Additional listing information.
* * * * *
(f) Labeling, advertisements, and other information to be submitted
upon request in accordance with paragraph (e) of this section may be
submitted by postal mail or electronically by email, but will not be
submitted using the FDA electronic device registration and listing
system. Electronic submissions of such information must comply with
part 11 of this chapter, except for the requirements in Sec. 11.10
(a), (c) through (h), and (k), and the corresponding requirements in
Sec. 11.30 of this chapter. The information provided in electronic
format must be in a form that we can process, review, and archive.
Sec. 807.30 [Redesignated as Sec. 807.28]
0
12. Redesignate Sec. 807.30 as Sec. 807.28.
0
13. Revise newly redesignated Sec. 807.28 to read as follows:
Sec. 807.28 Updating device listing information.
(a) Updating of device listing information is required if an
additional establishment begins to engage in any of the activities
described in Sec. 807.3(d) with respect to a listed device, such as
manufacturing, developing specifications, repackaging, relabeling, or
otherwise processing the device. Updating of the listing is also
required if an establishment begins performing another activity on or
to the device, or ceases to perform an activity on or to the device
that had previously been identified on the device listing.
(b) An owner or operator shall create a new device listing using
the FDA electronic device registration and listing system:
(1) If introducing into commercial distribution an exempt device
identified with a product code that is not currently listed by the
owner or operator; or
(2) If introducing into commercial distribution a non-exempt device
with an FDA premarket submission number that is not currently listed by
the owner or operator.
(c) All device listings for foreign establishments must be
submitted before the device may be imported or offered for import into
the United States.
(d) An owner or operator who discontinues commercial distribution
of a device shall discontinue the device listing using the FDA
electronic device registration and listing system. A device listing is
considered discontinued if:
(1) All devices under an exempt product code have been discontinued
or
(2) All devices associated with an FDA premarket submission number
have been discontinued.
(e) If commercial distribution of a discontinued device is resumed,
the owner or operator must reactivate the previously-discontinued
listing using the electronic device registration and listing system.
Any changes to the listing information for the product that is the
subject of the listing such as a new establishment, new activity, or
new proprietary name must be made using the electronic device
registration and listing system at the time the listing is reactivated.
(f) FDA will assign one listing number for all devices exempt from
premarket notification requirements under a single product code. For
products not exempt from premarket notification requirements, a single
listing number will be assigned by FDA for each FDA premarket
submission number.
0
14. Add Sec. 807.34 to subpart B to read as follows:
Sec. 807.34 Summary of requirements for owners or operators granted a
waiver from submitting required information electronically.
(a) For initial registration and listing, owners or operators who
have been granted a waiver from electronic filing using the procedures
set forth in Sec. 807.21(b) must send a letter containing all of the
registration and listing information described in Sec. Sec. 807.22,
807.25, (and Sec. 807.26 when such information is requested by FDA),
at the times described in Sec. 807.22, to: The Office of Compliance,
Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New Hampshire Ave., Bldg. 66, rm. 3521, Silver
Spring, MD 20993-0002.
(b) As specified in Sec. 807.22(b)(1) and (b)(3), all owners or
operators shall update their establishment registration and device
listings annually during the period beginning on October 1 and ending
on December 31 of each fiscal year.
(c) Failure to submit any of the required information on time, as
specified in Sec. 807.22(a) and (b), will put the establishment in a
``failed to register'' or ``failed to list'' status as applicable.
The establishment will not be considered active and the
establishment registration and device listing information may not
appear on the FDA Web site until the required information is submitted
to and processed by FDA.
0
15. Amend Sec. 807.35 by revising paragraphs (a) and (b) to read as
follows:
Sec. 807.35 Notification of registrant.
(a) The Food and Drug Administration will assign each device
establishment a registration number after verifying the initial
establishment registration information that has been submitted. The
owner or operator of the establishment will also be assigned an
identifying number. Both numbers will be sent to the official
correspondent by email, or by postal mail if the owner or operator has
been granted a waiver from the requirement to file registration and
listing information electronically.
(b) Owners or operators of device establishments who also
manufacture or process biological products (including devices licensed
under section 351 of the Public Health Service Act) or drug products at
the same establishment must also register and list those products under
part 607 or part 207 of this chapter, as appropriate. Registration and
listing for human blood and blood products, devices licensed under
section 351 of the Public Health Service Act, and licensed biological
products used in the manufacture of a device licensed under section 351
of the Public Health Service Act, are subject to part 607 of this
chapter; registration and listing for all other drug products
(including other biological products that are also regulated as drug
products) are subject to part 207 of this chapter.
* * * * *
0
16. Revise Sec. 807.37 to read as follows:
Sec. 807.37 Public availability of establishment registration and
device listing information.
(a) Establishment registration and device listing information is
available for public inspection in accordance with section 510(f) of
the Federal Food, Drug, and Cosmetic Act and will be posted on the FDA
Web site, with the exception of the information identified in paragraph
(b) of this section. Requests for information by persons who do not
have access to the Internet should be directed to the Office of
Compliance, Center for Devices and Radiological Health, Food and Drug
Administration, 10903 New
[[Page 45944]]
Hampshire Ave., Bldg. 66, rm. 3521, Silver Spring, MD 20993-0002. In
addition, there will be available for inspection at each of the Food
and Drug Administration district offices the same information for firms
within the geographical area of such district offices. Upon request,
verification of a registration number or location of a registered
establishment will be provided.
(b) The following listing information will not be available for
public inspection or posted on the FDA Web site:
(1) For contract manufacturers, contract sterilizers, and private
label manufacturers, the proprietary or brand name(s) under which a
device is marketed and the FDA-assigned premarket submission number, if
this information would reveal a confidential business relationship;
(2) FDA-assigned listing numbers.
0
17. Revise the heading of subpart C to read as set forth below:
Subpart C--Procedures for Foreign Device Establishments
0
18. Amend Sec. 807.40 by revising paragraphs (a) and (c) and by adding
paragraph (d) to read as follows:
Sec. 807.40 Establishment registration and device listing for foreign
establishments importing or offering for import devices into the United
States.
(a) Any establishment within any foreign country engaged in the
manufacture, preparation, propagation, compounding, or processing of a
device that is imported or offered for import into the United States
shall register such establishment and list such devices using the FDA
electronic device registration and listing system in conformance with
the procedures in this section, Sec. 807.41, and subpart B of this
part. The official correspondent for the foreign establishment shall
facilitate communication between the foreign establishment's management
and representatives of FDA for matters relating to the registration of
device establishments and the listing of device products.
* * * * *
(c) No device may be imported or offered for import into the United
States unless it is the subject of a device listing as required under
subpart B of this part and is manufactured, prepared, propagated,
compounded, or processed at a registered foreign establishment;
however, this restriction does not apply to devices imported or offered
for import under the investigational use provisions of part 812 of this
chapter.
(d) The device establishment registration and device listing
information shall be in the English language.
0
19. Add Sec. 807.41 to subpart C to read as follows:
Sec. 807.41 Identification of importers and persons who import or
offer for import.
(a) Upon initial registration, annually, and at the time of any
changes, each foreign establishment required to register and list as
provided in Sec. 807.40(a) must, using the FDA electronic device
registration and listing system, submit the name, address, telephone
and fax numbers, email address, and registration number, if any has
been assigned, of any importer (defined in Sec. 807.3(x)) of the
establishment's devices that is known to the foreign establishment. The
foreign establishment must also specify which of the establishment's
listed products each importer receives from the foreign establishment.
(b) Upon initial registration, annually, and at the time of any
changes, each foreign establishment required to register and list as
provided in Sec. 807.40(a) must, using the FDA electronic device
registration and listing system, submit the name, address, telephone
and fax numbers, email address, and registration number, if any has
been assigned, of each person who imports or offers for import the
establishment's devices into the United States. The term ``person who
imports or offers for import,'' which is defined in Sec. 807.3(y),
includes agents, brokers, or other parties used by the foreign
establishment to facilitate the import of its device into the United
States.
(c) For each individual or organization identified by the foreign
establishment under paragraphs (a) and (b) of this section, the foreign
establishment must submit to FDA electronically the current FDA
premarket submission number and any other identifying information that
is known to the establishment for each device being imported or offered
for import by the named individuals or organizations.
Dated: July 27, 2012.
Leslie Kux,
Assistant Commissioner for Policy.
[FR Doc. 2012-18764 Filed 8-1-12; 8:45 am]
BILLING CODE 4160-01-P