[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Proposed Rules]
[Pages 47085-47089]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2011-19733]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2011-N-0526]
Effective Date of Requirement for Premarket Approval for a
Pacemaker Programmer
AGENCY: Food and Drug Administration, HHS.
ACTION: Proposed rule.
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SUMMARY: The Food and Drug Administration (FDA) is proposing to require
the filing of a premarket approval application (PMA) or a notice of
completion of a product development protocol (PDP) for the class III
preamendments device pacemaker programmers. The agency is also
summarizing its proposed findings regarding the degree of risk of
illness or injury designed to be eliminated or reduced by requiring
this device to meet the statute's approval requirements and the
benefits to the public from the use of the devices. In addition, FDA is
announcing the opportunity for interested persons to request that the
agency change the classification of the aforementioned device based on
new information. This action implements certain statutory requirements.
DATES: Submit either electronic or written comments by November 2,
2011. Submit requests for a change in classification by August 19,
2011. FDA intends that, if a final rule based on this proposed rule is
issued, anyone who wishes to continue to market the device will need to
submit a PMA within 90 days of the effective date of the final rule.
Please see section XII of this document for the effective date of any
final rule that may publish based on this proposal.
ADDRESSES: You may submit comments, identified by [Docket No. FDA-2011-
N-0526], by any of the following methods:
Electronic Submissions
Submit electronic comments in the following way:
Federal eRulemaking Portal: http://www.regulations.gov.
Follow the instructions for submitting comments.
Written Submissions
Submit written submissions in the following ways:
Fax: 301-827-6870.
Mail/Hand delivery/Courier (for paper, disk, or CD-ROM
submissions): Division of Dockets Management (HFA-305), Food and Drug
Administration, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
Instructions: All submissions received must include the agency name
and Docket Number and Regulatory Information Number (RIN) (if a RIN
number has been assigned) for this rulemaking. All comments received
may be posted without change to http://www.regulations.gov, including
any personal information provided. For additional information on
submitting comments, see the Comments heading of the SUPPLEMENTARY
INFORMATION section of this document.
Docket: For access to the docket to read background documents or
comments received, go to http://www.regulations.gov and insert the
docket number(s), found in brackets in the heading of this document,
into the Search box and follow the prompts and/or go to the Division of
Dockets Management, 5630 Fishers Lane, Rm. 1061, Rockville, MD 20852.
FOR FURTHER INFORMATION CONTACT: Elias Mallis, Food and Drug
Administration, Center for Devices and Radiological Health, 10903 New
Hampshire Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993, 301-796-
6216.
SUPPLEMENTARY INFORMATION:
[[Page 47086]]
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 (the SMDA) (Pub. L. 101-
629), and 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), the Medical Devices
Technical Corrections Act (Pub. L. 108-214), and the Food and Drug
Administration Amendments Act of 2007 (Pub. L. 110-85), establish 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, reflecting 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) of the FD&C Act (21
U.S.C. 360e(b)(1)) establishes 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) of the FD&C Act is not required to have an approved
investigational device exemption (IDE) (see 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).
If a proposed 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 later of the
two dates, commercial distribution of the device is required to cease
since the device would be deemed adulterated under section 501(f) of
the FD&C Act.
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 later of the two dates, and the device does not comply
with IDE regulations, 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 or PDP has been
filed and may determine that such a request is appropriate for the
class III devices that are the subjects 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 a 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 for 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
[[Page 47087]]
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. Moreover, in this proposal, interested persons
are being offered the opportunity to request reclassification of any of
the devices.
II. Dates New Requirements Apply
In accordance with section 515(b) of the FD&C Act, FDA is proposing
to require that a PMA or a notice of completion of a PDP be filed with
the agency for class III devices within 90 days after issuance of any
final rule based on this proposal. An applicant whose device was
legally in commercial distribution before May 28, 1976, or whose device
has been found to be substantially equivalent to such a device, will be
permitted to continue marketing such class III devices during FDA's
review of the PMA or notice of completion of the PDP. FDA intends to
review any PMA for the device within 180 days, and any notice of
completion of a PDP for the device within 90 days of the date of
filing. FDA cautions that under section 515(d)(1)(B)(i) of the FD&C
Act, the agency may not enter into an agreement to extend the review
period for a PMA beyond 180 days unless the agency finds that ``the
continued availability of the device is necessary for the public
health.''
FDA intends that under 21 CFR 812.2(d), the preamble to any final
rule based on this proposal will state that, as of the date on which
the filing of a PMA or a notice of completion of a PDP is required to
be filed, the exemptions from the requirements of the IDE regulations
for preamendments class III devices in 21 CFR 812.2(c)(1) and (c)(2)
will cease to apply to any device that is: (1) Not legally on the
market on or before that date, or (2) legally on the market on or
before that date but for which a PMA or notice of completion of a PDP
is not filed by that date, or for which PMA approval has been denied or
withdrawn.
If a PMA or notice of completion of a PDP for a class III device is
not filed with FDA within 90 days after the date of issuance of any
final rule requiring premarket approval for the device, commercial
distribution of the device must cease. The device may be distributed
for investigational use only if the requirements of the IDE regulations
are met. The requirements for significant risk devices include
submitting an IDE application to FDA for its review and approval. An
approved IDE is required to be in effect before an investigation of the
device may be initiated or continued under 21 CFR 812.30. FDA,
therefore, cautions that IDE applications should be submitted to FDA at
least 30 days before the end of the 90-day period after the issuance of
the final rule to avoid interrupting investigations.
III. Proposed Findings With Respect to Risks and Benefits
As required by section 515(b) of the FD&C Act, FDA is publishing
its proposed findings regarding: (1) The degree of risk of illness or
injury designed to be eliminated or reduced by requiring that this
device have an approved PMA or a declared completed PDP, and (2) the
benefits to the public from the use of the device.
These findings are based on the reports and recommendations of the
advisory committee (panel) for the classification of this device 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 this device type can be found in the
following proposed and final rules and notices published in the Federal
Register: 44 FR 13382, March 9, 1979; 45 FR 7907-7971, February 5,
1980; and 52 FR 17736, May 11, 1987.
IV. Device Subject to This Proposal--Pacemaker Programmers (21 CFR
870.3700)
A. Identification
A pacemaker programmer is a device used to change noninvasively one
or more of the electrical operating characteristics of a pacemaker.
B. Summary of Data
The Cardiovascular Device Classification Panel recommended that
this device be classified as class III because the panel also
recommended that pacemakers be classified into class III. The panel
believed that premarket approval was necessary to assure the safety and
effectiveness of pacemakers, which are life-supporting devices, and
that the same level of control was necessary for both devices because
pacemaker programmers must be designed to operate with a specific
pacemaker as a system. The panel believed that general controls alone
would not provide sufficient control over the performance
characteristics of this device, that a performance standard would not
provide reasonable assurance of the safety and effectiveness of the
device, and, moreover, that there are insufficient data to establish a
standard to provide such assurance. Consequently, the panel believed
that premarket approval was necessary to assure the safety and
effectiveness of the device. FDA continues to agree with the panel's
recommendation.
C. Risks to Health
1. Cardiac arrhythmias or electrical shock: Excessive electrical
leakage current can disturb the normal electrophysiology of the heart,
leading to the onset of cardiac arrhythmias.
2. Improper pacemaker operation: Inadequate design of the device's
programming function can cause the pacemaker to lose its sensing or
pacing ability, or to pace at an improper rate.
3. Misdiagnosis: Inadequate design of the device's ability to sense
pacemaker function can lead to the generation of inaccurate diagnostic
data. If inaccurate diagnostic data are used in managing the patient,
the physician may prescribe a course of treatment that places the
patient at risk unnecessarily.
4. Inability to change pacing therapy: Inadequate matching of the
programmer to the pacemaker could lead to a situation where the
pacemaker could not be programmed, thereby preventing a needed change
in pacing therapy and placing the patient at risk unnecessarily.
V. PMA Requirements
A PMA for this device must include the information required by
section 515(c)(1) of the FD&C Act. Such a PMA should also include a
detailed discussion of the risks identified previously, as well as a
discussion of the effectiveness of the device for which premarket
approval is sought. In addition, a PMA must include all data and
information on: (1) Any risks known, or that should be reasonably
known, to the applicant that have not been identified in this document;
(2) the effectiveness of the device that is the subject of the
application; and (3) full
[[Page 47088]]
reports of all preclinical and clinical information from investigations
on the safety and effectiveness of the device for which premarket
approval is sought.
A PMA must include valid scientific evidence to demonstrate
reasonable assurance of the safety and effectiveness of the device for
its intended use (see 21 CFR 860.7(c)(2)). Valid scientific evidence is
``evidence from well-controlled investigations, partially controlled
studies, studies and objective trials without matched controls, well-
documented case histories conducted by qualified experts, and reports
of significant human experience with a marketed device, from which it
can fairly and responsibly be concluded by qualified experts that there
is reasonable assurance of the safety and effectiveness of a device
under its conditions of use. * * * Isolated case reports, random
experience, reports lacking sufficient details to permit scientific
evaluation, and unsubstantiated opinions are not regarded as valid
scientific evidence to show safety or effectiveness.'' (21 CFR
860.7(c)(2))
VI. PDP Requirements
A PDP for this device may be submitted in lieu of a PMA, and must
follow the procedures outlined in section 515(f) of the FD&C Act. A PDP
must provide: (1) A description of the device, (2) preclinical trial
information (if any), (3) clinical trial information (if any), (4) a
description of the manufacturing and processing of the device, (5) the
labeling of the device, and (6) all other relevant information about
the device. In addition, the PDP must include progress reports and
records of the trials conducted under the protocol on the safety and
effectiveness of the device for which the completed PDP is sought.
VII. Opportunity To Request a Change in Classification
Before requiring the filing of a PMA or notice of completion of a
PDP for a device, FDA is required by section 515(b)(2)(A)(i) through
(b)(2)(A)(iv) of the FD&C Act and 21 CFR 860.132 to provide an
opportunity for interested persons to request a change in the
classification of the device based on new information relevant to the
classification. Any proceeding to reclassify the device will be under
the authority of section 513(e) of the FD&C Act.
A request for a change in the classification of this device is to
be in the form of a reclassification petition containing the
information required by Sec. 860.123, including new information
relevant to the classification of the device.
The agency advises that to ensure timely filing of any such
petition, any request should be submitted to the Division of Dockets
Management (see ADDRESSES) and not to the address provided in Sec.
860.123(b)(1). If a timely request for a change in the classification
of these devices is submitted, the agency will, within 60 days after
receipt of the petition, and after consultation with the appropriate
FDA resources, publish an order in the Federal Register that either
denies the request or gives notice of its intent to initiate a change
in the classification of the device in accordance with section 513(e)
of the FD&C Act and 21 CFR 860.130 of the regulations.
VIII. 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.
IX. Analysis of Impacts
FDA has examined the impacts of the proposed rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Pub. L. 104-4). Executive
Order 12866 directs 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 proposed rule is not a significant regulatory action as defined by
the Executive order.
The Regulatory Flexibility Act requires agencies to analyze
regulatory options that would minimize any significant impact of a rule
on small entities. There has been only one 510(k) submission assigned
to this product code within the past 15 years. Upon review of this
record, the agency determined that this was done in error, which has
been corrected. Accordingly, since it has been determined that all of
the affected devices have fallen into disuse; FDA has concluded that
there is little or no interest in marketing these devices in the
future. Therefore, the agency proposes to certify that the proposed
rule, if issued as a final rule, would not have a significant economic
impact on a substantial number of small entities. We specifically
request detailed comment regarding the appropriateness of our
assumptions regarding the potential economic impact of this proposed
rule.
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
proposed rule to result in any 1-year expenditure that would meet or
exceed this amount.
FDA proposes to certify that this proposed rule, if issued as a
final rule, would not have a significant economic impact. We base this
determination on an analysis of registration and listing and other data
for the device. There have been no 510(k) submissions for pacemaker
programmers since 1995 with the exception of one 510(k) submission
cleared in 2009 for a Pacing System Analyzer cleared for use with a PMA
approved programmer. This device was inappropriately reviewed as a
510(k) submission, because this device should have been regulated under
PMA. Programmers currently marketed are capable of programming all
implantable cardiac devices including pacemakers and defibrillators.
Because these programmers interact with products covered under several
class III product codes including adaptive rate pacemakers (LWP);
implantable defibrillators (LWS); cardiac resynchronization pacemakers
(CRT-P, NKE) and implantable defibrillators (CRT-D, NIK) they have been
entirely reviewed within the PMA program for more than a decade.
This information is summarized in table 1 below as follows:
[[Page 47089]]
Table 1--Summary of Electronic Registration and Listing Information
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Replaced by
Device name Product code 510(k) or PMA? Last listed Last marketed approved
technology?
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Pacemaker Programmer............................................... KRG 510(k) 2011 1990s 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 proposed rule
would not have a significant economic impact. We specifically request
detailed comment regarding the appropriateness of our assumptions
regarding the potential economic impact of this proposed rule.
X. Federalism
FDA has analyzed this proposed rule in accordance with the
principles set forth in Executive Order 13132. FDA has determined that
the proposed rule, if finalized, would not contain policies that would
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 tentatively concludes that the proposed 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.
XI. Paperwork Reduction Act of 1995
This proposed 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 part 812 have been approved under
OMB Control No. 0910-0078; the collections of information in 21 CFR
part 807 subpart E have been approved under OMB Control No. 0910-0120;
the collections of information in 21 CFR 814 subpart B have been
approved under OMB Control No. 0910-0231; and the collections of
information under 21 CFR 801 have been approved under OMB Control No.
0910-0485.
XII. Proposed Effective Date
FDA is proposing that any final rule based on this proposal become
effective on the date of its publication in the Federal Register or at
a later date if stated in the final rule.
XIII. Comments
Interested persons may submit to the Division of Dockets Management
(see ADDRESSES) either electronic or written comments regarding this
document. It is only necessary to send one set of comments. It is no
longer necessary to send two copies of mailed comments. Identify
comments with the docket number found in brackets in the heading of
this document. Received comments may be seen in the Division of Dockets
Management between 9 a.m. and 4 p.m., Monday through Friday.
List of Subjects in 21 CFR Part 870
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, it is
proposed that 21 CFR part 870 be amended as follows:
PART 870--CARDIOVASCULAR DEVICES
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.
2. Section 870.3700 is amended by revising paragraphs (a) and (c)
to read as follows:
Sec. 870.3700 Pacemaker programmers.
(a) Identification. A pacemaker programmer is a device used to
noninvasively change one or more of the electrical operating
characteristics of a pacemaker.
(b) * * *
(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 2, 2011, for any pacemaker
programmer that was in commercial distribution before May 28, 1976, or
that has, on or before November 2, 2011, been found to be substantially
equivalent to any pacemaker programmer that was in commercial
distribution before May 28, 1976. Any other pacemaker programmer shall
have an approved PMA or declared completed PDP in effect before being
placed in commercial distribution.
Dated: July 29, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-19733 Filed 8-3-11; 8:45 am]
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