Effective Date of Requirement for Premarket Approval for an Implantable Pacemaker Pulse Generator, 44872-44877 [2011-18957]

Agencies

• Food and Drug Administration
• DEPARTMENT OF HEALTH AND HUMAN SERVICES

[Federal Register Volume 76, Number 144 (Wednesday, July 27, 2011)]
[Proposed Rules]
[Pages 44872-44877]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-18957]


=======================================================================
-----------------------------------------------------------------------

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2011-N-0522]


Effective Date of Requirement for Premarket Approval for an 
Implantable Pacemaker Pulse Generator

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

-----------------------------------------------------------------------

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 implantable pacemaker pulse generator. 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 
the device to meet the statute's approval requirements and the benefits 
to the public from the use of the device. 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 October 25, 
2011. Submit requests for a change in classification by August 11, 
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 XIII 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-0522, by any of the following methods:

[[Page 44873]]

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: https://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 for this rulemaking. All comments received may be 
posted without change to https://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 https://www.regulations.gov and insert the 
docket number, 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, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1538, Silver Spring, MD 20993, 301-796-6216.

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 (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 of 2004 (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 part 807 (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 
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 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).
    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

[[Page 44874]]

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 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 Sec.  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 Sec.  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 Sec.  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 committees (panels) for the classification of these devices 
along with information submitted in response to the 515(i) Order that 
published in the Federal Register of April 9, 2009 (74 FR 16214), 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 the following dates: 
March 9, 1979 (44 FR 13373); February 5, 1980 (45 FR 7907); and May 11, 
1987 (52 FR 17736).

IV. Device Subject to This Proposal--Implantable Pacemaker Pulse 
Generator (21 CFR 870.3610)

A. Identification

    An implantable pacemaker pulse generator is a device that has a 
power supply and electronic circuits that produce a periodic electrical 
pulse to stimulate the heart. The power supply may be a pacemaker 
battery although, as discussed in section X of this document, FDA has 
no record of the pacemaker battery ever being marketed. This device is 
used as a substitute for the heart's intrinsic pacing system to correct 
both intermittent and continuous cardiac rhythm disorders. This device 
may include triggered, inhibited, and asynchronous devices implanted in 
the human body.

B. Summary of Data

    The Cardiovascular Devices Panel recommended that the implantable 
pacemaker pulse generator (which includes the internal pacemaker 
battery) be classified into class III because the device is implanted 
and life-supporting and presented a potential unreasonable risk of 
illness or injury. The power supply may be a pacemaker battery 
although, as discussed under section X of this document, FDA has no 
record of the pacemaker battery ever being marketed. The panel 
indicated that

[[Page 44875]]

although a proposed standard had been written, it did not cover all of 
the performance characteristics of the device and that this standard 
was not widely accepted. The panel indicated that general controls 
alone would not provide sufficient control over the performance 
characteristics of the device and that sufficient scientific and 
medical data did not exist to establish a complete standard to assure 
the safety and effectiveness of particular aspects of the device. 
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. Failure To Pace
    A failure of the electronic circuitry or early battery depletion 
can cause failure to pace the patient's heart. Failure to pace could 
result in a dangerously slow heart rate (or in extreme cases, no heart 
beat at all), which could result in weakness, dizziness, fainting or 
even death.
2. Improper Pacing Rate
    An electronic circuit failure or an inaccurate rate controller in 
the circuit can cause improper pacing rates, which could be too fast or 
too slow. Improper pacing rates may result in symptoms of fatigue, 
chest discomfort, shortness of breath, dizziness, or fainting.
3. Arrhythmias
    A sensing failure of the pacemaker during vulnerable periods of the 
cardiac cycle can induce cardiac arrhythmias, in particular, 
dangerously fast arrhythmias. In this case, dangerously fast 
arrhythmias may lead to chest pain, shortness of breath, dizziness, 
fainting or even death.
4. Improper Sensing
    Electromagnetic interference with pacemaker electronics, loose 
connections, or sensing circuitry failures may cause improper sensing 
by the pacemaker, which can lead to failure to pace, improper pacing 
cycle, and/or arrhythmias.
5. Tissue Damage
    If the materials, surface finish, or cleanliness of this device are 
inadequate, tissue damage can occur.
6. Unintended Stimulation
    Pacing pulses may stimulate unintended nerve or muscle, resulting 
in uncomfortable contractions of the chest wall muscles or of the 
diaphragm.
7. Development of Pacemaker Syndrome
    Pacemaker syndrome may result from suboptimal atrioventricular (AV) 
synchrony or AV dyssynchrony; this could cause an uncomfortable cardiac 
awareness including palpitations, fatigue, dizziness, shortness of 
breath and near-fainting.
8. Other Complications
    Other risks of pacemaker implantation include infection, erosion, 
fibrotic tissue formation, body rejection phenomena, hematoma, 
myopotential sensing, and additional surgery for replacement. Risks are 
also associated with pacemaker lead implantation. These are not 
discussed in this document.

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 the following: (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 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. 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.

VIII. 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 (21 CFR 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

[[Page 44876]]

513(e) of the FD&C Act and 21 CFR 860.130 of the regulations.

IX. 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.

X. Analysis of Impacts

    FDA has examined the impacts of the proposed 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 proposed rule is not a 
significant regulatory action as defined by 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. There have been no 510(k) submissions for 
implantable pacemaker devices since 1999, there is no record of 
pacemaker batteries ever being marketed, and both of these devices are 
in a state of disuse. Accordingly, 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.
    This proposed rule, if issued as a final rule, would be likely to 
have no significant impact. We base this determination on an analysis 
of our Registration and Listing, 510(k) and Premarket Approval 
Application (PMA) database information. There have been no 510(k) 
submissions for implantable pacemaker pulse generators since 1999, with 
the exception of one 510(k) submission cleared in 2001 that was 
erroneously coded as an implantable pacemaker pulse generator (product 
code DXY), but is actually for an external pacemaker and is being 
corrected. Current pacemakers have newer features and capabilities that 
have rendered them not substantially equivalent to the devices cleared 
under 510(k) prior to 1999, which are obsolete. Current pacemakers are 
marketed under a PMA; in some cases the product code DXY has been 
erroneously applied. In addition, there have been no valid 510(k) 
submissions for pacemaker batteries for implantable pacemakers, which 
also fall under the product code DSZ also under 21 CFR 870.3610. Two 
510(k) submissions have been received for DSZ devices since 1976, but 
they are believed to be miscoded. The Agency has no record of pacemaker 
batteries ever being marketed.
    This information is summarized in table 1 of this document.

                                           Table 1--Summary of Electronic Registration and Listing Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                   Replaced by  approved
            Device name                   Product code           510(k) or PMA?           Last listed           Last marketed            technology?
--------------------------------------------------------------------------------------------------------------------------------------------------------
Implantable Pacemaker Pulse          DXY...................  Both..................  2011.................  1990s................  Yes.\1\
 Generator.
Pacemaker Battery..................  DSZ...................  510(k)................  No Record............  No Record............  No.\2\
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ Implantable pacemaker pulse generators have been submitted as PMAs since the early 1980s. The product code DXY has been erroneously applied to many
  of these PMA products. The last 510(k) submission for a DXY device was cleared in 1999.
\2\ Pacemaker batteries are not separately marketed products. They are internal to implantable pacemakers.
 

    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.

XI. 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.

XII. Paperwork Reduction Act of 1995

    This proposed 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 are currently approved under OMB 
Control No. 0910-0078; the collections of information in part 807, 
subpart E are currently approved under OMB Control No. 0910-0120; the 
collections of information in 21 CFR Part 814, subpart B are currently 
approved under OMB Control No. 0910-0231; and the collections of 
information under 21 CFR Part 801 are currently approved under OMB 
Control No. 0910-0485.

[[Page 44877]]

XIII. 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.

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 870.3610 is amended by revising paragraphs (a) and (c) 
to read as follows:


Sec.  870.3610  Implantable pacemaker pulse generator.

    (a) Identification. An implantable pacemaker pulse generator is a 
device that has a power supply and electronic circuits that produce a 
periodic electrical pulse to stimulate the heart. This device is used 
as a substitute for the heart's intrinsic pacing system to correct both 
intermittent and continuous cardiac rhythm disorders. This device may 
include triggered, inhibited, and asynchronous modes and is implanted 
in the human body.
* * * * *
    (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 [A DATE WILL BE ADDED 90 DAYS AFTER 
DATE OF PUBLICATION OF A FUTURE FINAL RULE IN THE FEDERAL REGISTER], 
for any implantable pacemaker pulse generator that was in commercial 
distribution before May 28, 1976, or that has, on or before [A DATE 
WILL BE ADDED 90 DAYS AFTER DATE OF PUBLICATION OF A FUTURE FINAL RULE 
IN THE FEDERAL REGISTER], been found to be substantially equivalent to 
any implantable pacemaker pulse generator that was in commercial 
distribution before May 28, 1976. Any other implantable pacemaker pulse 
generator shall have an approved PMA or declared completed PDP in 
effect before being placed in commercial distribution.

    Dated: July 22, 2011.
 Nancy K. Stade,
 Deputy Director for Policy, Center for Devices and Radiological 
Health.
[FR Doc. 2011-18957 Filed 7-26-11; 8:45 am]
BILLING CODE 4160-01-P