
[Federal Register Volume 77, Number 121 (Friday, June 22, 2012)]
[Rules and Regulations]
[Pages 37573-37576]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-15244]


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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: Final rule.

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SUMMARY: The Food and Drug Administration (FDA) is issuing a final rule 
to require the filing of a premarket approval application (PMA) or a 
notice of completion of a product development protocol (PDP) for 
implantable pacemaker pulse generators. The Agency has summarized its 
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. This action implements certain statutory requirements.

DATES: This rule is effective September 20, 2012.

FOR FURTHER INFORMATION CONTACT: Melissa Burns, Center for Devices and 
Radiological Health, Food and Drug Administration, 10903 New Hampshire 
Ave., Bldg. 66, Rm. 1646, Silver Spring, MD 20993-0002, 301-796-5616.

SUPPLEMENTARY INFORMATION: 

I. Background--Regulatory Authorities

    The Federal Food, Drug, and Cosmetic Act (the FD&C Act), as amended 
by the Medical Device Amendments of 1976 (the 1976 amendments) (Pub. L. 
94-295), the Safe Medical Devices Act of 1990 (SMDA) (Pub. L. 101-629), 
the Food and Drug Administration Modernization Act of 1997 (FDAMA) 
(Pub. L. 105-115), the Medical Device User Fee and Modernization Act of 
2002 (Pub. L. 107-250), and the Food and Drug Administration Amendments 
Act of 2007 (Pub. L. 110-85), among other amendments, established a 
comprehensive system for the regulation of medical devices intended for 
human use. Section 513 of the FD&C Act (21 U.S.C. 360c) established 
three categories (classes) of devices, depending on the regulatory 
controls needed to provide reasonable assurance of their safety and 
effectiveness. The three categories of devices are class I (general 
controls), class II (special controls), and class III (premarket 
approval).
    Under section 513 of the FD&C Act, devices that were in commercial 
distribution before the enactment of the 1976 amendments, May 28, 1976 
(generally referred to as preamendments

[[Page 37574]]

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) is not required to 
have an approved investigational device exemption (IDE) (see part 812 
(21 CFR part 812)) contemporaneous with its interstate distribution 
until the date identified by FDA in the final rule requiring the 
submission of a PMA for the device. At that time, an IDE is required 
only if a PMA has not been submitted or a PDP completed.
    Section 515(b)(2)(A) of the FD&C Act provides that a proceeding to 
issue a final rule to require premarket approval shall be initiated by 
publication of a notice of proposed rulemaking containing: (1) The 
regulation; (2) proposed findings with respect to the degree of risk of 
illness or injury designed to be eliminated or reduced by requiring the 
device to have an approved PMA or a declared completed PDP and the 
benefit to the public from the use of the device; (3) an opportunity 
for the submission of comments on the proposed rule and the proposed 
findings; and (4) an opportunity to request a change in the 
classification of the device based on new information relevant to the 
classification of the device.
    Section 515(b)(2)(B) of the FD&C Act provides that if FDA receives 
a request for a change in the classification of the device within 15 
days of the publication of the notice, FDA shall, within 60 days of the 
publication of the notice, consult with the appropriate FDA advisory 
committee and publish a notice denying the request for change in 
reclassification or announcing its intent to initiate a proceeding to 
reclassify the device under section 513(e) of the FD&C Act. Section 
515(b)(3) of the FD&C Act provides that FDA shall, after the close of 
the comment period on the proposed rule and consideration of any 
comments received, issue a final rule to require premarket approval or 
publish a document terminating the proceeding together with the reasons 
for such termination. If FDA terminates the proceeding, FDA is required 
to initiate reclassification of the device under section 513(e) of the 
FD&C Act, unless the reason for termination is that the device is a 
banned device under section 516 of the FD&C Act (21 U.S.C. 360f).
    When a rule to require premarket approval for a preamendments 
device is finalized, section 501(f)(2)(B) of the FD&C Act (21 U.S.C. 
351(f)(2)(B)) requires that a PMA or notice of completion of a PDP for 
any such device be filed within 90 days of the date of issuance of the 
final rule or 30 months after the final classification of the device 
under section 513 of the FD&C Act, whichever is later. If a PMA or 
notice of completion of a PDP is not filed by the latter of the two 
dates, commercial distribution of the device must cease because the 
device would be deemed adulterated under section 501(f).
    The device may, however, be distributed for investigational use if 
the manufacturer, importer, or other sponsor of the device complies 
with the IDE regulations. If a PMA or notice of completion of a PDP is 
not filed by the latter of the two dates, and no IDE is in effect, the 
device is deemed to be adulterated within the meaning of section 
501(f)(1)(A) of the FD&C Act, and subject to seizure and condemnation 
under section 304 of the FD&C Act (21 U.S.C. 334), if its distribution 
continues. Shipment of devices in interstate commerce will be subject 
to injunction under section 302 of the FD&C Act (21 U.S.C. 332), and 
the individuals responsible for such shipment will be subject to 
prosecution under section 303 of the FD&C Act (21 U.S.C. 333). In the 
past, FDA has requested that manufacturers take action to prevent the 
further use of devices for which no PMA has been filed and may 
determine that such a request is appropriate for the class III device 
that is the subject of this regulation.
    The FD&C Act does not permit an extension of the 90-day period 
after issuance of a final rule within which an application or notice is 
required to be filed. The House Report on the 1976 amendments states 
that ``* * * [t]he thirty month `grace period' afforded after 
classification of a device into class III * * * is sufficient time for 
manufacturers and importers to develop the data and conduct the 
investigations necessary to support an application of premarket 
approval'' (H. Rept. 94-853, 94th Cong., 2d sess. 42 (1976)).
    The SMDA added section 515(i) to the FD&C Act requiring FDA to 
review the classification of preamendments class III devices for which 
no final rule requiring the submission of PMAs has been issued, and to 
determine whether or not each device should be reclassified into class 
I or class II or remain in class III. For devices remaining in class 
III, the SMDA directed FDA to develop a schedule for issuing 
regulations to require premarket approval. The SMDA does not, however, 
prevent FDA from proceeding immediately to rulemaking under section 
515(b) of the FD&C Act on specific devices, in the interest of public 
health, independent of the procedures of section 515(i). Proceeding 
directly to rulemaking under section 515(b) of the FD&C Act is 
consistent with Congress' objective in enacting section 515(i), i.e., 
that preamendments class III devices for which PMAs have not been 
previously required either be reclassified to class I or class II or be 
subject to the requirements of premarket approval.
    In the Federal Register of May 6, 1994 (59 FR 23731) (the May 6, 
1994, notice), FDA issued a notice of availability of a preamendments 
class III devices strategy document. The strategy document set forth 
FDA's plans for implementing the provisions of section 515(i) of the 
FD&C Act for preamendments class III devices for which FDA had not yet 
required premarket approval.

[[Page 37575]]

    In the Federal Register of July 27, 2011 (76 FR 44872) (the July 
27, 2011, proposed rule), FDA published a proposed rule to require the 
filing under section 515(b) of the FD&C Act of a PMA or notice of 
completion of a PDP for the implantable pacemaker pulse generator. In 
accordance with section 515(b)(2)(A) of the FD&C Act, FDA included in 
the preamble of the proposed rule the Agency's tentative findings with 
respect to the degree of risk of illness or injury designed to be 
eliminated or reduced by requiring the devices to meet the premarket 
approval requirements of the FD&C Act, and the benefits to the public 
from use of the device. The July 27, 2011, proposed rule also provided 
an opportunity for interested persons to submit comments on the 
proposed rule and the Agency's findings. Under section 515(b)(2)(B) of 
the FD&C Act, FDA provided an opportunity for interested persons to 
request a change in the classification of the devices based on new 
information relevant to its classification. Any petition requesting a 
change in classification of the implantable pacemaker pulse generator 
was required to be submitted by August 11, 2011. The comment period for 
the implantable pacemaker pulse generator closed October 25, 2011.
    FDA received one comment on the proposed rule for the implanted 
pacemaker pulse generator. The comment was a general statement 
supporting the requirements for filing of a PMA for this device. The 
comment did not recommend any changes to the proposed rule. FDA 
received no petitions requesting a change in the classification of the 
device.

II. Findings With Respect to Risks and Benefits

    As required by section 515(b) of the FD&C Act, FDA published its 
findings regarding: (1) The degree of risk of illness or injury 
designed to be eliminated or reduced by requiring that 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 were published in the 
July 27, 2011, proposed rule.
    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, 
(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 the implantable pacemaker pulse 
generator can be found in the following proposed and final rules 
published in the Federal Register on these dates: March 9, 1979 (44 FR 
13373); February 5, 1980 (45 FR 7940); and May 11, 1987 (52 FR 17732 at 
17736).

III. The Final Rule

    Under section 515(b)(3) of the FD&C Act, FDA is adopting its 
findings as published in the preamble to the proposed rule. FDA is 
issuing this final rule to require premarket approval of these generic 
types of devices for class III preamendments devices by revising part 
870 (21 CFR part 870).
    Under the final rule, a PMA or a notice of completion of a PDP is 
required to be filed on or before 90 days after the date of publication 
of the final rule in the Federal Register, for any of these class III 
preamendments devices that were in commercial distribution before May 
28, 1976, or that has been found by FDA to be substantially equivalent 
to such a device on or before 90 days after the date of publication of 
the final rule in the Federal Register. An approved PMA or a declared 
completed PDP is required to be in effect for any such devices on or 
before 180 days after FDA files the application. Any other class III 
preamendments device subject to this rule that was not in commercial 
distribution before May 28, 1976, is required to have an approved PMA 
or a declared completed PDP in effect before it may be marketed.
    If a PMA or a notice of completion of a PDP for any of the class 
III preamendments devices is not filed on or before the 90th day past 
the effective date of this regulation, that device will be deemed 
adulterated under section 501(f)(1)(A) of the FD&C Act, and commercial 
distribution of the device must cease immediately. The device may, 
however, be distributed for investigational use, if the requirements of 
the IDE regulations (part 812) are met.

IV. Environmental Impact

    The Agency has determined under 21 CFR 25.30(h) that this action is 
of a type that does not individually or cumulatively have a significant 
effect on the human environment. Therefore, neither an environmental 
assessment nor an environmental impact statement is required.

V. Analysis of Impacts

    FDA has examined the impacts of the final rule under Executive 
Order 12866, Executive Order 13563, the Regulatory Flexibility Act (5 
U.S.C. 601-612), and the Unfunded Mandates Reform Act of 1995 (Pub. L. 
104-4). Executive Orders 12866 and 13563 direct Agencies to assess all 
costs and benefits of available regulatory alternatives and, when 
regulation is necessary, to select regulatory approaches that maximize 
net benefits (including potential economic, environmental, public 
health and safety, and other advantages; distributive impacts; and 
equity). The Agency believes that this final rule is not a significant 
regulatory action under Executive Order 12866.
    The Regulatory Flexibility Act requires Agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. There have been no 510(k) submissions for 
implantable pacemaker pulse generators since 1999, and there is no 
record of pacemaker batteries ever being marketed. Accordingly, it has 
been determined that all of these devices are in a state of disuse, and 
FDA has concluded that there is little or no interest in marketing 
these devices in the future. Therefore, the Agency certifies that the 
final rule will not have a significant economic impact on a substantial 
number of small entities.
    Section 202(a) of the Unfunded Mandates Reform Act of 1995 requires 
that Agencies prepare a written statement, which includes an assessment 
of anticipated costs and benefits, before proposing ``any rule that 
includes any Federal mandate that may result in the expenditure by 
State, local and tribal governments, in the aggregate, or by the 
private sector, of $100,000,000 or more (adjusted annually for 
inflation) in any one year.'' The current threshold after adjustment 
for inflation is $139 million, using the most current (2011) Implicit 
Price Deflator for the Gross Domestic Product. FDA does not expect this 
final rule to result in any 1-year expenditure that would meet or 
exceed this amount.
    FDA has concluded that this final rule will not have a significant 
impact. We base this determination on an analysis of our Registration 
and Listing, 510(k) and 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. This record has been 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

[[Page 37576]]

for pacemaker batteries for implantable pacemakers, which also fall 
under the product code DSZ also under Sec.  870.3610. Two 510(k) 
submissions have been received for DSZ devices since 1976, but they 
were miscoded, which has been corrected. The Agency has no record of 
pacemaker batteries ever being marketed.
    This information is summarized in table 1 of this document as 
follows:

                       Table 1--Summary of Electronic Registration and Listing Information
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                                                                                                 Replaced by
          Device name               Product code         Last listed     Last valid  510(k)        approved
                                                                               cleared           technology?
----------------------------------------------------------------------------------------------------------------
Implantable Pacemaker Pulse      DXY...............  2012..............  1999..............  Yes.\1\
 Generator.
Pacemaker Battery..............  DSZ...............  No Record.........  No Record.........  No.\2\
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\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.
\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 final rule 
would not have a significant economic impact.

VI. Federalism

    FDA has analyzed this final rule in accordance with the principles 
set forth in Executive Order 13132. FDA has determined that the rule 
does not contain policies that have substantial direct effects on the 
States, on the relationship between the National Government and the 
States, or on the distribution of power and responsibilities among the 
various levels of government. Accordingly, the Agency has concluded 
that the rule does not contain policies that have federalism 
implications as defined in the Executive order and, consequently, a 
federalism summary impact statement is not required.

VII. Paperwork Reduction Act of 1995

    This final rule refers to currently approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in part 812 have been approved under OMB 
control number 0910-0078; the collections of information in part 807, 
subpart E, have been approved under OMB control number 0910-0120; the 
collections of information in 21 CFR part 814, subpart B, have been 
approved under OMB control number 0910-0231; and the collections of 
information under 21 CFR part 801 have been approved under OMB control 
number 0910-0485.

List of Subjects in 21 CFR Part 870

    Medical devices.

    Therefore, under the Federal Food, Drug, and Cosmetic Act and under 
authority delegated to the Commissioner of Food and Drugs, 21 CFR part 
870 is amended as follows:

PART 870--CARDIOVASCULAR DEVICES

0
1. The authority citation for 21 CFR part 870 continues to read as 
follows:

    Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.


0
2. Section 870.3610 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 September 20, 2012, for any 
implantable pacemaker pulse generator device that was in commercial 
distribution before May 28, 1976, or that has, on or before September 
20, 2012, been found to be substantially equivalent to any implantable 
pacemaker pulse generator device that was in commercial distribution 
before May 28, 1976. Any other implantable pacemaker pulse generator 
device shall have an approved PMA or declared completed PDP in effect 
before being placed in commercial distribution.

    Dated: June 18, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-15244 Filed 6-21-12; 8:45 am]
BILLING CODE 4160-01-P


