Effective Date of Requirement for Premarket Approval for a Pacemaker Programmer, 47085-47089 [2011-19733]

Agencies

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

[Federal Register Volume 76, Number 150 (Thursday, August 4, 2011)]
[Proposed Rules]
[Pages 47085-47089]
From the Federal Register Online via the Government Printing 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: 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 and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) 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(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
--------------------------------------------------------------------------------------------------------------------------------------------------------
                                                                                                                                           Replaced  by
                            Device name                                Product code    510(k) or PMA?    Last listed     Last marketed       approved
                                                                                                                                           technology?
--------------------------------------------------------------------------------------------------------------------------------------------------------
Pacemaker Programmer...............................................             KRG           510(k)             2011            1990s              Yes
--------------------------------------------------------------------------------------------------------------------------------------------------------

    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]
BILLING CODE P