[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Rules and Regulations]
[Pages 50663-50667]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-20664]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 870 and 884
[Docket No. FDA-2010-N-0412]
Effective Date of Requirement for Premarket Approval for Three
Class III Preamendments Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule
to require the filing of a premarket approval application (PMA) or a
notice of completion of a product development protocol (PDP) for the
following three class III preamendments devices: Ventricular bypass
(assist) device; pacemaker repair or replacement material; and female
condom. The Agency has summarized its findings regarding the degree of
risk of illness or injury designed to be eliminated or reduced by
requiring the devices to meet the statute's approval requirements and
the benefits to the public from the use of the devices. This action
implements certain statutory requirements.
DATES: This rule is effective August 23, 2011.
[[Page 50664]]
FOR FURTHER INFORMATION CONTACT: Michael Ryan, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1615, Silver Spring, MD 20993-0002, 301-796-6283.
SUPPLEMENTARY INFORMATION:
I. Background--Regulatory Authorities
The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L.
94-295), the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629),
the Food and Drug Administration Modernization Act of 1997 (FDAMA)
(Pub. L. 105-115), the Medical Device User Fee and Modernization Act of
2002 (Pub. L. 107-250), and the Food and Drug Administration Amendments
Act of 2007 (Pub. L. 110-85), among other amendments, established a
comprehensive system for the regulation of medical devices intended for
human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established
three categories (classes) of devices, depending on the regulatory
controls needed to provide reasonable assurance of their safety and
effectiveness. The three categories of devices are class I (general
controls), class II (special controls), and class III (premarket
approval).
Under section 513 of the FD&C Act, devices that were in commercial
distribution before the enactment of the 1976 amendments, May 28, 1976
(generally referred to as preamendments devices), are classified after
FDA has: (1) Received a recommendation from a device classification
panel (an FDA advisory committee); (2) published the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices) are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and 21 CFR part 807.
A preamendments device that has been classified into class III may
be marketed by means of premarket notification procedures (510(k)
process) without submission of a PMA until FDA issues a final
regulation under section 515(b) of the FD&C Act (21 U.S.C. 360e(b))
requiring premarket approval. Section 515(b)(1) established the
requirement that a preamendments device that FDA has classified into
class III is subject to premarket approval. A preamendments class III
device may be commercially distributed without an approved PMA or a
notice of completion of a PDP until 90 days after FDA issues a final
rule requiring premarket approval for the device, or 30 months after
final classification of the device under section 513 of the FD&C Act,
whichever is later. Also, a preamendments device subject to the
rulemaking procedure under section 515(b) is not required to have an
approved investigational device exemption (IDE) (see part 812 (21 CFR
part 812)) contemporaneous with its interstate distribution until the
date identified by FDA in the final rule requiring the submission of a
PMA for the device. At that time, an IDE is required only if a PMA has
not been submitted or a PDP completed.
Section 515(b)(2)(A) of the FD&C Act provides that a proceeding to
issue a final rule to require premarket approval shall be initiated by
publication of a notice of proposed rulemaking containing: (1) The
regulation; (2) proposed findings with respect to the degree of risk of
illness or injury designed to be eliminated or reduced by requiring the
device to have an approved PMA or a declared completed PDP and the
benefit to the public from the use of the device; (3) an opportunity
for the submission of comments on the proposed rule and the proposed
findings; and (4) an opportunity to request a change in the
classification of the device based on new information relevant to the
classification of the device.
Section 515(b)(2)(B) of the FD&C Act provides that if FDA receives
a request for a change in the classification of the device within 15
days of the publication of the notice, FDA shall, within 60 days of the
publication of the notice, consult with the appropriate FDA advisory
committee and publish a notice denying the request for change in
reclassification or announcing its intent to initiate a proceeding to
reclassify the device under section 513(e) of the FD&C Act. Section
515(b)(3) of the FD&C Act provides that FDA shall, after the close of
the comment period on the proposed rule and consideration of any
comments received, issue a final rule to require premarket approval or
publish a document terminating the proceeding together with the reasons
for such termination. If FDA terminates the proceeding, FDA is required
to initiate reclassification of the device under section 513(e) of the
FD&C Act, unless the reason for termination is that the device is a
banned device under section 516 of the FD&C Act (21 U.S.C. 360f).
When a rule to require premarket approval for a preamendments
device is finalized, section 501(f)(2)(B) of the FD&C Act (21 U.S.C.
351(f)(2)(B)) requires that a PMA or notice of completion of a PDP for
any such device be filed within 90 days of the date of issuance of the
final rule or 30 months after the final classification of the device
under section 513 of the FD&C Act, whichever is later. If a PMA or
notice of completion of a PDP is not filed by the latter of the two
dates, commercial distribution of the device must cease since the
device would be deemed adulterated under section 501(f).
The device may, however, be distributed for investigational use if
the manufacturer, importer, or other sponsor of the device complies
with the IDE regulations. If a PMA or notice of completion of a PDP is
not filed by the latter of the two dates, and no IDE is in effect, the
device is deemed to be adulterated within the meaning of section
501(f)(1)(A) of the FD&C Act, and subject to seizure and condemnation
under section 304 of the FD&C Act (21 U.S.C. 334), if its distribution
continues. Shipment of devices in interstate commerce will be subject
to injunction under section 302 of the FD&C Act (21 U.S.C. 332), and
the individuals responsible for such shipment will be subject to
prosecution under section 303 of the FD&C Act (21 U.S.C. 333). In the
past, FDA has requested that manufacturers take action to prevent the
further use of devices for which no PMA has been filed and may
determine that such a request is appropriate for the class III device
that is the subject of this regulation.
The FD&C Act does not permit an extension of the 90-day period
after issuance of a final rule within which an application or notice is
required to be filed. The House Report on the 1976 amendments states
that ``* * * [t]he thirty month `grace period' afforded after
classification of a device into class III * * * is sufficient time for
manufacturers and importers to develop the data and conduct the
investigations necessary to support an application of
[[Page 50665]]
premarket approval'' (H. Rept. 94-853, 94th Cong., 2d sess. 42 (1976)).
The SMDA added section 515(i) to the FD&C Act requiring FDA to
review the classification of preamendments class III devices for which
no final rule requiring the submission of PMAs has been issued, and to
determine whether or not each device should be reclassified into class
I or class II or remain in class III. For devices remaining in class
III, the SMDA directed FDA to develop a schedule for issuing
regulations to require premarket approval. The SMDA does not, however,
prevent FDA from proceeding immediately to rulemaking under section
515(b) of the FD&C Act on specific devices, in the interest of public
health, independent of the procedures of section 515(i). Proceeding
directly to rulemaking under section 515(b) of the FD&C Act is
consistent with Congress' objective in enacting section 515(i), i.e.,
that preamendments class III devices for which PMAs have not been
previously required either be reclassified to class I or class II or be
subject to the requirements of premarket approval.
In the Federal Register of May 6, 1994 (59 FR 23731) (the May 6,
1994, notice), FDA issued a notice of availability of a preamendments
class III devices strategy document. The strategy document set forth
FDA's plans for implementing the provisions of section 515(i) of the
FD&C Act for preamendments class III devices for which FDA had not yet
required premarket approval. FDA divided this universe of devices into
three groups as referenced in the May 6, 1994, notice.
In the Federal Register of August 25, 2010 (75 FR 52294) (the
August 25, 2010, proposed rule), FDA published a proposed rule to
require the filing under section 515(b) of the FD&C Act of a PMA or
notice of completion of a PDP for four premendments class III devices:
Ventricular (bypass) assist device; pacemaker repair or replacement
material; female condom; and transilluminator for breast evaluation. In
accordance with section 515(b)(2)(A) of the FD&C Act, FDA included in
the preamble of the proposal the Agency's tentative findings with
respect to the degree of risk of illness or injury designed to be
eliminated or reduced by requiring the device to meet the premarket
approval requirements of the FD&C Act, and the benefits to the public
from use of the device. The August 25, 2010, proposed rule also
provided an opportunity for interested persons to submit comments on
the proposed rule and the Agency's findings. Under section 515(b)(2)(B)
of the FD&C Act, FDA provided an opportunity for interested persons to
request a change in the classification of the device based on new
information relevant to its classification. Any petition requesting a
change in classification of the devices was required to be submitted by
September 9, 2010. The comment period closed November 23, 2010.
FDA received no comments on the proposed rule. FDA received one
petition requesting a change in the classification of the
transilluminator for breast evaluation. FDA has yet to resolve the
request; therefore, the transilluminator for breast evaluation is not
subject to this final rule.
II. Findings With Respect to Risks and Benefits
Under section 515(b)(3) of the FD&C Act, FDA is adopting its
findings as published in the August 25, 2010, proposed rule with the
exception of the findings related to the transilluminator for breast
evaluation. As required by section 515(b) of the FD&C Act, FDA
published its findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring that these
devices have an approved PMA or a declared completed PDP and (2) the
benefits to the public from the use of the devices.
These findings are based on the reports and recommendations of the
advisory committees (panels) for the classification of these devices
along with information submitted in response to the 515(i) Order, (74
FR 16214, April 9, 2009), and any additional information that FDA has
encountered. Additional information regarding the risks as well as
classification associated with these device types can be found in the
following proposed and final rules published in the Federal Register on
these dates: Cardiovascular Devices--part 870 (21 CFR part 870) (44 FR
13284, March 9, 1979 and 45 FR 7904, February 5, 1980, 52 FR 17732 at
17736, May 11, 1987); and Obstetrical and Gynecological Devices--part
884 (21 CFR part 884) (64 FR 31164, June 10, 1999, and 65 FR 31454, May
18, 2000).
III. The Final Rule
Under section 515(b)(3) of the FD&C Act, FDA is adopting its
findings as published in the preamble to the proposed rule with the
exception of the findings related to the transilluminator for breast
evaluation. FDA is issuing this final rule to require premarket
approval of these generic types of devices for class III preamendments
devices by revising parts 870 and 884.
Under the final rule, a PMA or a notice of completion of a PDP is
required to be filed on or before 90 days after the date of publication
of the final rule in the Federal Register, for any of these class III
preamendments devices that were in commercial distribution before May
28, 1976, or that has been found by FDA to be substantially equivalent
to such a device on or before 90 days after the date of publication of
the final rule in the Federal Register. An approved PMA or a declared
completed PDP is required to be in effect for any such devices on or
before 180 days after FDA files the application. Any other class III
preamendments device subject to this rule that was not in commercial
distribution before May 28, 1976, is required to have an approved PMA
or a declared completed PDP in effect before it may be marketed.
If a PMA or a notice of completion of a PDP for any of these class
III preamendments devices is not filed on or before the 90th day past
the effective date of this regulation, that device will be deemed
adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial
distribution of the device will be required to cease immediately. The
device may, however, be distributed for investigational use, if the
requirements of the IDE regulations (part 812) are met.
IV. 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.
V. Analysis of 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 there have been no premarket submissions for
these devices in the past 5 years and all of the affected devices have
fallen into disuse, FDA has
[[Page 50666]]
concluded that there is little or no interest in marketing these
devices in the future. Therefore, 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 $136 million, using the most current (2010) 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.
FDA has concluded that this final rule will not have a significant
impact. We base this determination on an analysis of registration and
listing and other data for the affected devices. Two of the devices
affected by this final rule, the female condom and ventricular bypass
device, have never appeared in FDA's electronic registration and
listing database. These devices were identified as preamendment
devices, but since their classification, the Agency has no record of
them ever being marketed. In addition, these devices represent older
technologies that have since been replaced by newer technologies
currently being marketed under a PMA.
The final affected device, pacemaker repair and replacement
material, is a material that can be used in multiple devices that was
last listed in 2001, and the Agency is aware of no evidence that the
device has been marketed since 1991. In addition, on the increasingly
rare occasions when a pacemaker is repaired today, the repair is done
with materials specific to the approved device. This information is
summarized in table 1 of this document as follows.
Table 1--Summary of Electronic Registration and Listing Information
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Replaced by approved
Device name Product code 510(k) or PMA? Last listed Last marketed technology?
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Female Condom..................... OBY................... No................... Never Listed........ 1930s............... Yes.
Ventricular Bypass Device......... OKR................... No................... Never Listed........ No Record........... Yes.
Pacemaker Repair and Replacement.. KFJ................... No................... 2001................ 1991................ Yes.
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Based on our review of electronic product registration and listing
and other data, FDA concludes that there is currently little or no
interest in marketing the affected devices and that the final rule will
not have a significant economic impact.
VI. 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.
VII. Paperwork Reduction Act of 1995
This final rule refers to currently 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 part 812 have been approved under OMB
control number 0910-0078; the collections of information in 21 CFR part
807, subpart E, have been approved under OMB control number 0910-0120;
the collections of information in 21 CFR part 814, subpart B, have been
approved under OMB control number 0910-0231; and the collections of
information under 21 CFR part 801 have been approved under OMB control
number 0910-0485.
List of Subjects in 21 CFR Parts 870 and 884
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
870 and 884 are amended as follows:
PART 870--CARDIOVASCULAR DEVICES
0
1. The authority citation for 21 CFR part 870 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Section 870.3545 is amended by revising paragraph (c) to read as
follows:
Sec. 870.3545 Ventricular bypass (assist) device.
* * * * *
(c) Date PMA or notice of completion of PDP is required. A PMA or
notice of completion of a PDP is required to be filed with the Food and
Drug Administration on or before November 21, 2011, for any ventricular
bypass (assist) device that was in commercial distribution before May
28, 1976, or that has, on or before November 21, 2011, been found to be
substantially equivalent to any ventricular bypass (assist) device that
was in commercial distribution before May 28, 1976. Any other
ventricular bypass (assist) device shall have an approved PMA or
declared completed PDP in effect before being placed in commercial
distribution.
0
3. Section 870.3710 is amended by revising paragraph (c) to read as
follows:
Sec. 870.3710 Pacemaker repair or replacement material.
* * * * *
(c) Date PMA or notice of completion of PDP is required. A PMA or
notice of completion of a PDP is required to be filed with the Food and
Drug Administration on or before November 21, 2011, for any pacemaker
repair or replacement material device that was in commercial
distribution before May 28, 1976, or that has, on or before November
21, 2011, been found to be substantially equivalent to any pacemaker
repair or replacement material device that was in commercial
distribution before May 28, 1976. Any other pacemaker repair or
replacement material device shall have an approved PMA or declared
completed PDP in effect before being placed in commercial distribution.
[[Page 50667]]
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
0
4. The authority citation for 21 CFR part 884 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
5. Section 884.5330 is amended by revising paragraph (c) to read as
follows:
Sec. 884.5330 Female condom.
* * * * *
(c) Date PMA or notice of completion of PDP is required. A PMA or
notice of completion of a PDP is required to be filed with the Food and
Drug Administration on or before November 21, 2011, for any female
condom that was in commercial distribution before May 28, 1976, or that
has, on or before November 21, 2011, been found to be substantially
equivalent to any female condom that was in commercial distribution
before May 28, 1976. Any other female condom shall have an approved PMA
or declared completed PDP in effect before being placed in commercial
distribution.
Dated: August 10, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological
Health.
[FR Doc. 2011-20664 Filed 8-15-11; 8:45 am]
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