Document ID: FDA-2011-N-0505-0001
Agency: fda
Document Type: Proposed Rule
Title: Requirement for Premarket Approval for Cardiovascular Permanent Pacemaker Electrode
Posted Date: 2011-08-08T04:00Z

[Federal Register Volume 76, Number 152 (Monday, August 8, 2011)]
[Proposed Rules]
[Pages 48058-48062]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-19959]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2011-N-0505]

Effective Date of Requirement for Premarket Approval for 
Cardiovascular Permanent Pacemaker Electrode

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 following 
class III preamendments device: Cardiovascular permanent pacemaker 
electrode. 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 device. In addition, FDA is announcing the opportunity for 
interested persons to request that the Agency change the classification 
of the cardiovascular permanent pacemaker electrode based on new 
information. This action implements certain statutory requirements.

DATES: Submit either electronic or written comments by November 7, 
2011. Submit requests for a change in classification by August 23, 
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 XI of this document for the proposed 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-0505, 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 No. FDA-2011-N-0505 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 20993-0002, 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 (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

[[Page 48059]]

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 device that is the subject of this regulation.
    The FD&C Act does not permit an extension of the 90-day period 
after issuance of a final rule within which an application or 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 the device.

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

[[Page 48060]]

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 on these dates: (45 FR 7907 at 7971, February 5, 1980; 52 FR 
17736, May 11, 1987; and 60 FR 41986, August 14, 1995).

IV. Device Subject to This Proposal

    Cardiovascular Permanent or Temporary Pacemaker Electrode; 
Permanent Pacemaker Electrode (21 CFR 870.3680(b)).

A. Identification

    A permanent pacemaker electrode is a device consisting of flexible 
insulated electrical conductors with one end connected to an 
implantable pacemaker pulse generator and the other end applied to the 
heart. The device is used to transmit a pacing electrical stimulus from 
the pulse generator to the heart and/or to transmit the electrical 
signal of the heart to the pulse generator.

B. Summary of Data

    The Cardiovascular Devices Classification Panel recommended that 
this device be classified into class III as permanent pacemaker 
electrodes are permanent implants providing life-supporting or life-
sustaining therapy. Over time, the devices that have been designed and 
developed have evolved and are widely variable from model to model as 
well as from manufacturer to manufacturer. These designs are generally 
more complex and of smaller sizes which may increase risk of failure 
and introduce new failure modes. Accordingly, this has limited the 
ability to develop comprehensive performance standards which would 
apply to all aspects of pacemaker lead design, testing, and use. 
Adequate performance standards have not yet been developed. The 
potential safety and effectiveness risks, unsuitability of general and 
special controls, long-term use as permanent implants of life-
sustaining therapy, and documented field failures warrant 
classification of this device as class III.

C. Risks to Health

     Material risks. The material properties of 
pacemaker leads, including mechanical, electrical, biostability, 
biocompatibility, corrosion and other characteristics can affect acute 
and chronic performance.
     Design risks. Lead designs may introduce 
features or geometries that depart from traditional designs, 
geometries, or sizes and which may result in degradation of performance 
and safety of use.
     Manufacturing risks. Manufacturing variation, 
the introduction of more complex and smaller designs, or quality system 
failures may introduce device defects that may not be identified with 
bench testing or acute in vivo studies.
     Clinical-use risks. Thromboembolism, 
perforation, tissue reaction (exit block), dislodgement, infection, air 
embolism, muscle/nerve stimulation, stenosis, and erosion/extrusion may 
occur as a result of the clinical use and/or device malfunction.

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 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 Sec.  860.7(c)(2) (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.'' (Sec.  860.7(c)(2)).

VI. PDP Requirements

    A PDP for this device may be submitted instead 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 (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 this device 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

[[Page 48061]]

classification of the device in accordance with section 513(e) of the 
FD&C Act and Sec.  860.139 (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, 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. Because none of the manufacturers of affected 
products are small businesses, the Agency proposes to certify that the 
final rule would not have a significant economic impact on a 
substantial number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local, and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $136 million, using the most current (2010) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
proposed rule to result in any one-year expenditure that would meet or 
exceed this amount.

A. Costs of the Proposed Rule

    Under the proposed rule, FDA would require producers in the 
cardiovascular permanent pacemaker electrode industry to obtain PMA or 
establish a PDP before marketing new products. Similarly, producers of 
cardiovascular permanent pacemaker electrodes that are already on the 
market would need to submit PMA applications or establish PDPs in order 
to continue commercial distribution of these products. Based on an 
analysis of registration and listing data, manufacturer Web sites, and 
responses to previous Federal Register requests for comment; FDA 
estimates that 5 to 10 manufacturers are marketing approximately 18 to 
23 devices that would be affected by this proposed rule. We therefore 
estimate that the proposed rule would generate between 18 and 23 PMA or 
PDP submissions. FDA has estimated an upper bound on the cost of PMA at 
approximately $1,000,000 (see, for example, 73 FR 7501, February 8, 
2008), and we assume that the cost of a PDP is roughly equal to that of 
a PMA; this yields a rule-induced upfront cost of between $18 and $23 
million. We lack data with which to estimate how the burden of this 
cost would be distributed among device manufacturers, patients and 
insurance providers.
    For a new product (i.e., a cardiovascular permanent pacemaker 
electrode not currently on the market), the rule-induced cost would be 
the difference between the cost of preparing and submitting a premarket 
approval application and the cost of preparing and submitting a 510(k) 
application. However, FDA has not received any submissions for new 
devices of the type subject to the proposed rule since August 2004. We 
expect the recent pattern of zero submissions to continue; therefore, 
the proposed rule would not generate submission costs on an ongoing 
basis.
    Some producers of devices that are subject to the proposed rule 
could be dissuaded from seeking approval by the cost of submitting a 
PMA application or by a low expectation that FDA would grant approval 
for their products. In these cases, producers would experience a rule-
induced cost equal to the foregone expected profit on the withdrawn or 
withheld cardiovascular permanent pacemaker electrodes, which is 
necessarily less than the cost of PMA submission (otherwise, the 
producers in question would not be dissuaded from seeking PMA). 
Additionally, there would be a welfare loss experienced by consumers 
who would, in the absence of the proposed rule, use the cardiovascular 
permanent pacemaker electrodes that would be withdrawn or withheld from 
the market as a result of the call for PMA or PDP. Due to the lack of 
sufficient market data, we cannot quantify these consumers' welfare 
loss. FDA requests comment on this issue and on all methods and results 
of our cost estimation.
    In addition to the cost to industry of preparing and submitting 
PMAs or PDPs, the proposed rule would impose incremental review costs 
on FDA. Geiger (2005) (Ref. 1) estimated that, for devices reviewed by 
FDA's Center for Devices and Radiological Health in 2003 and 2004, 
review costs averaged $563,000 per PMA. Updated for inflation (using 
U.S. Department of Commerce, 2011) (Ref. 2) to 2010 dollars, this 
average review cost becomes $653,000 per PMA. Thus, the proposed rule's 
review-related costs are expected to be between $11.8 million (18 x 
$653,000) and $15.0 million (23 x $653,000). A portion of this total 
would be paid by industry in the form of user fees, with the remainder 
coming from general revenues. FDA's Data universal numbering system 
database reveals that the manufacturers affected by this proposed rule 
have annual revenues over $100 million, so they would not be eligible 
for small business user fees. The standard user fee is currently set at 
$236,298 for a premarket application (PMA or PDP) (75 FR 45632 at 
45643), so user fees would likely cover $4.3 million (= 18*$236,298) to 
$5.4 million (= 23*$236,298) of FDA review costs, with the remaining 
$7.5 to $9.6 million coming from general revenues.

B. Benefits of the Proposed Rule

    The proposed requirement for premarket approval applications or 
product development protocols for cardiovascular permanent pacemaker 
electrodes would produce social benefits equal to the value of the 
information generated by the safety and effectiveness tests that 
producers would be required to conduct as part of the PMA or PDP 
process. Provided first to FDA, this information would eventually 
assist physicians, patients and insurance providers in making more 
informed decisions about these devices. FDA expects there to be 
approximately 18 to 23 PMA or PDP submissions as a result of the 
proposed rule, but we are unable to quantify the value of information 
associated with each submission. We request comment on this issue.

X. 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

[[Page 48062]]

(44 U.S.C. 3501-3520). The collections of information in 21 CFR part 
812 have been approved under OMB control number 0910-0078; the 
collections of information in 21 CFR part 807, subpart E have been 
approved under OMB control number 0910-0120; the collections of 
information in 21 CFR part 814, subpart B have been approved under OMB 
control number 0910-0231; and the collections of information under 21 
CFR part 801 have been approved under OMB control number 0910-0485.

XI. 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.

XII. 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.

XIII. References

    The following references have been placed on display in the 
Division of Dockets Management (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, Rm. 1061, Rockville, MD 20852, and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday. 
(FDA has verified the Web site address, but FDA is not responsible for 
any subsequent changes to the Web site after this document publishes in 
the Federal Register.)

1. Geiger, Dale R, ``FY 2003 and 2004 Unit Costs for the Process of 
Medical Device Review,'' September 2005, http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/Overview/MedicalDeviceUserFeeandModernizationActMDUFMA/umc109216.
2. U.S. Department of Commerce, Bureau of Economic Analysis, 
National Income and Product Accounts Table 1.1.9, http://www.bea.gov/national/nipaweb/SelectTable.asp, accessed March 25, 
2011.

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 870.3680 is amended by revising paragraph (c) to read as 
follows:

Sec.  870.3680  Cardiovascular permanent or temporary pacemaker 
electrode.

* * * * *
    (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 permanent pacemaker electrode 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 permanent pacemaker electrode that was in commercial distribution 
before May 28, 1976. Any other permanent pacemaker electrode shall have 
an approved PMA or declared completed PDP in effect before being placed 
in commercial distribution.

    Dated: August 2, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-19959 Filed 8-5-11; 8:45 am]
BILLING CODE 4160-01-P