[Federal Register Volume 76, Number 200 (Monday, October 17, 2011)]
[Proposed Rules]
[Pages 64223-64227]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-26625]



[[Page 64223]]

Vol. 76

Monday,

No. 200

October 17, 2011

Part III





Department of Health and Human Services





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 Food and Drug Administration





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21 CFR Part 870





Cardiovascular Devices; Reclassification of External Pacemaker Pulse 
Generator Devices; Draft Guidance for Industry and Food and Drug 
Administration Staff; Class II Special Controls Guidance Document: 
External Pacemaker Pulse Generator; Availability; Proposed Rule and 
Notice

Federal Register / Vol. 76 , No. 200 / Monday, October 17, 2011 / 
Proposed Rules

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

21 CFR Part 870

[Docket No. FDA-2011-N-0650]


Cardiovascular Devices; Reclassification of External Pacemaker 
Pulse Generator Devices

AGENCY: Food and Drug Administration, HHS.

ACTION: Proposed rule.

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SUMMARY: The Food and Drug Administration (FDA) is proposing to 
reclassify the external pacemaker pulse generator preamendments class 
III device into class II (special controls). FDA is proposing this 
reclassification on its own initiative based on new information. FDA is 
taking this action under the Federal Food, Drug, and Cosmetic Act (the 
FD&C Act), as amended by the Medical Device Amendments of 1976 (the 
1976 amendments), the Safe Medical Devices Act of 1990 (SMDA), the Food 
and Drug Administration Modernization Act of 1997 (FDAMA), and the 
Medical Device User Fee and Modernization Act of 2002 (MDUFMA).

DATES: Submit either electronic or written comments by January 17, 
2012. 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-0650 by any of the following methods:

Electronic Submissions

    Submit electronic comments in the following way:
     Federal eRulemaking Portal: http://www.regulations.gov. 
Follow the instructions for submitting comments.

Written Submissions

    Submit written submissions in the following ways:
     Fax: 301-827-6870.
     Mail/Hand delivery/Courier (for paper, disk, or CD-ROM 
submissions): Division of Dockets Management (HFA-305), Food and Drug 
Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.
    Instructions: All submissions received must include the Agency name 
and docket number and Regulatory Information Number (RIN) (if a RIN 
number has been assigned) for this rulemaking. All comments received 
may be posted without change to http://www.regulations.gov, including 
any personal information provided. For additional information on 
submitting comments, see the ``Comments'' heading of the SUPPLEMENTARY 
INFORMATION section of this document.
    Docket: For access to the docket to read background documents or 
comments received, go to http://www.regulations.gov and insert the 
docket number, 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 FD&C Act, as amended by the 1976 amendments (Pub. L. 94-295), 
the SMDA (Pub. L. 101-629), FDAMA (Pub. L. 105-115), MDUFMA (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 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 premarket approval application (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 513(e) of the FD&C Act governs reclassification of 
classified preamendments devices. This section provides that FDA may, 
by rulemaking, reclassify a device (in a proceeding that parallels the 
initial classification proceeding) based upon ``new information.'' FDA 
can initiate a reclassification under section 513(e) or an interested 
person may petition FDA to reclassify a preamendments device. The term 
``new information,'' as used in section 513(e) of the FD&C Act, 
includes information developed as a result of a reevaluation of the 
data before the Agency when the device was originally classified, as 
well as information not presented, not available, or not developed at 
that time. (See, e.g., Holland Rantos v. United States Department of 
Health, Education, and Welfare, 587 F.2d 1173, 1174 n.1 (D.C. Cir. 
1978); Upjohn v. Finch, 422 F.2d 944 (6th Cir. 1970); Bell v. Goddard, 
366 F.2d 177 (7th Cir. 1966).)
    Reevaluation of the data previously before the Agency is an 
appropriate basis for subsequent regulatory action where the 
reevaluation is made in light of newly available regulatory authority 
(see Bell v. Goddard, supra, 366 F.2d at 181; Ethicon, Inc. v. FDA, 762 
F.Supp. 382, 389-91 (D.D.C. 1991)), or in light of changes in ``medical 
science.'' (See Upjohn v. Finch, supra, 422 F.2d at 951.) Whether data 
before the Agency are past or new data, the ``new information'' to 
support reclassification under section 513(e) must be ``valid 
scientific evidence,'' as defined in section 513(a)(3) of the FD&C Act 
(21 U.S.C. 360c(a)(3)) and 21 CFR 860.7(c)(2). (See, e.g., General 
Medical Co. v. FDA, 770 F.2d 214 (D.C. Cir. 1985); Contact Lens Assoc. 
v. FDA, 766 F.2d 592 (D.C. Cir.), cert. denied, 474 U.S. 1062 (1985)).

[[Page 64225]]

    FDA relies upon ``valid scientific evidence'' in the classification 
process to determine the level of regulation for devices. To be 
considered in the reclassification process, the valid scientific 
evidence upon which the Agency relies must be publicly available. 
Publicly available information excludes trade secret and/or 
confidential commercial information, e.g., the contents of a pending 
premarket approval application (PMA). (See section 520(c) of the FD&C 
Act (21 U.S.C. 360j(c)).) Section 520(h)(4) of the FD&C Act, added by 
FDAMA, provides that FDA may use, for reclassification of a device, 
certain information in a PMA 6 years after the application has been 
approved. This includes information from clinical and preclinical tests 
or studies that demonstrate the safety or effectiveness of the device 
but does not include descriptions of methods of manufacture or product 
composition and other trade secrets.
    FDAMA added a new section 510(m) to the FD&C Act. New section 
510(m) of the FD&C Act provides that a class II device may be exempted 
from the premarket notification requirements under section 510(k) of 
the FD&C Act, if the Agency determines that premarket notification is 
not necessary to assure the safety and effectiveness of the device.

II. Regulatory History of the Device

    In the preamble to the proposed rule (44 FR 13284, March 9, 1979 
and 44 FR 13372, March 9, 1979), the Cardiovascular Devices Panel 
recommended that external pacemaker pulse generators be classified into 
class III because the device provided temporary life-support and that 
certain kinds of failures could cause this device to emit inappropriate 
electrical signals, which could cause cardiac irregularities and death. 
The panel indicated that general controls alone would not be sufficient 
and that there was not enough information to establish a performance 
standard. Consequently, the panel believed that premarket approval was 
necessary to assure the safety and effectiveness of the device. In 
1980, FDA classified external pacemaker pulse generators into class III 
after receiving no comments on the proposed rule. In 1987, FDA 
published a clarification by inserting language in the codified 
language stating that no effective date had been established for the 
requirement for premarket approval for external pacemaker pulse 
generator devices (52 FR 17732, May 11, 1987).
    In 2009, FDA published an order for the submission of information 
on external pacemaker pulse generators by August 7, 2009 (74 FR 16214, 
April 9, 2009). In response to that order, FDA received 
reclassification petitions from three device manufacturers who all 
recommended that external pacemaker pulse generators be reclassified to 
class II. The manufacturers stated that safety and effectiveness of 
these devices may be assured by design and maintenance (special 
controls), consideration of risks involved with the device, and an 
independent verification that appropriate standard operating procedures 
are in place and being followed.

III. Device Description

    An external 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, which is used outside the body, is 
used as a temporary substitute for the heart's intrinsic pacing system 
until a permanent pacemaker can be implanted, or to control irregular 
heartbeats in patients following cardiac surgery or a myocardial 
infarction. The device may have adjustments for impulse strength, 
duration, R-wave sensitivity, and other pacing variables.

IV. Proposed Reclassification

    FDA is proposing that the device subject to this proposal be 
reclassified from class III to class II. FDA believes that the 
identified special controls would provide reasonable assurance of 
safety and effectiveness. Therefore, in accordance with sections 513(e) 
and 515(i) of the FD&C Act and 21 CFR 860.130, based on new information 
with respect to the devices, FDA, on its own initiative, is proposing 
to reclassify this preamendments class III device into class II. The 
Agency has identified special controls that would provide reasonable 
assurance of their safety and effectiveness. FDA has considered 
external pacemaker pulse generators in accordance with the reserved 
criteria and determined that the device does require premarket 
notification. The Agency does not intend to exempt this proposed class 
II device from premarket notification (510(k)) submission as provided 
for under section 510(m) of the FD&C Act.

V. Risks to Health

    After considering the information from 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 and any additional information that FDA 
has encountered, FDA has evaluated the risks to health associated with 
the use of external pacemaker pulse generators and determined that the 
following risks to health are associated with its use:
    1. Failure to pace--A failure of the electronic circuitry can cause 
failure to pace the patient's heart;
    2. Improper pacing leading to high rate--Electric failure, 
electromagnetic interference, or improper programming can cause 
sustained high rate pacing, which can lead to arrhythmias such as 
pulseless ventricular tachycardia;
    3. Improper pacing leading to unwanted stimulation--Pacing during 
vulnerable periods of the cardiac cycle or at higher than programmer 
amplitude can induce cardiac arrhythmias; and
    4. Micro/macro shocks--Uncontrolled leakage currents or patient 
auxiliary currents can cause an electric shock resulting in an 
arrhythmia or cardiac tissue damage.

VI. Summary of Reasons for Reclassification

    FDA believes that external pacemaker pulse generators should be 
reclassified into class II because special controls, in addition to 
general controls, can be established to provide reasonable assurance of 
the safety and effectiveness of the device. In addition, there is now 
adequate effectiveness information sufficient to establish special 
controls to provide such assurance.

VII. Summary of Data Upon Which the Reclassification Is Based

    Since 1980 when FDA classified external pacemaker pulse generators 
into class III, sufficient evidence has been developed to support a 
reclassification to class II with special controls. The effectiveness 
and acceptability of pacing for the treatment of various cardiac 
arrhythmias has been demonstrated in extensive clinical studies and is 
summarized in the American College of Cardiology/American Heart 
Association Guidelines for implantable cardiac pulse generators. 
Several key performance standards have been developed and used to 
support marketing applications over the years, which address various 
aspects of design and performance and have been determined to be 
sufficient in the establishment of requirements for market entry.

VIII. Proposed Special Controls--Related Documents

    FDA believes that the special controls described in the guidance 
document ``Class II Special Controls Guidance Document: External 
Pacemaker Pulse Generator'' are sufficient to mitigate the risks to 
health described in section V of

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this document. Elsewhere in this issue of the Federal Register, FDA is 
announcing the availability of a draft guidance document that, when 
finalized, would serve as a special control, if FDA reclassifies this 
device. If adopted, following the effective date of a final rule 
classifying the device, any firm submitting a 510(k) premarket 
notification for the device would need to address the issues covered in 
the special control guidance. However, the firm would need to show only 
that its device meets the recommendations of the guidance or in some 
other way provides equivalent assurances of safety and effectiveness.

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. Because this proposed rule will not introduce new 
requirements for manufacturers of external pacemaker pulse generators, 
the Agency proposes to certify 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 $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 rule proposes to reclassify external pacemaker pulse generator 
devices into class II with special controls from its current 
classification as preamendment class III. Manufacturers of new or 
modified external pacemaker pulse generators would continue to be 
subject to premarket notification requirements as they have already 
been marketed through premarket notification procedures. The rule would 
require compliance with the proposed special controls, in addition to 
general controls. As described in the special controls guidance 
document, however, the standards for labeling, safety, and performance 
testing for these devices reflect current FDA requirements for 
marketing clearance.
    The information and data requirements for 510(k) submissions remain 
unchanged. Thus, there would be no additional manufacturer costs 
associated with this proposed rule. While reclassification is unlikely 
to result in any procedural changes in how the affected devices are 
reviewed, the proposed rule will ensure that manufacturers understand 
the requirements by clarifying FDA's expectations for premarket 
submissions in the special controls guidance document.
    The Regulatory Flexibility Act requires agencies to analyze 
regulatory options that would minimize any significant impact of a rule 
on small entities. According to FDA's Registration and Listing 
database, there are seven establishments that currently market external 
pacemaker pulse generator devices. Because this proposed rule would 
impose no additional regulatory burdens, the Agency proposes to certify 
that this proposed rule would not have a significant economic impact on 
a substantial number of small entities.

XI. Federalism

    FDA has analyzed this proposed rule in accordance with the 
principles set forth in Executive Order 13132. Section 4(a) of the 
Executive order requires Agencies to ``construe * * * a Federal statute 
to preempt State law only where the statute contains an express 
preemption provision or there is some other clear evidence that the 
Congress intended preemption of State law, or where the exercise of 
State authority conflicts with the exercise of Federal authority under 
the Federal statute.'' Federal law includes an express preemption 
provision that preempts certain state requirements ``different from or 
in addition to'' certain Federal requirements applicable to devices. 
(See section 521 of the FD&C Act (21 U.S.C. 360k); Medtronic, Inc. v. 
Lohr, 518 U.S. 470 (1996); and Riegel v. Medtronic, Inc. 128 S. Ct. 999 
(2008)). If this proposed rule is made final, the special controls 
established by the final rule would create ``requirements'' for 
specific medical devices under 21 U.S.C. 360(k), even though product 
sponsors have some flexibility in how they meet those requirements (Cf. 
Papike v. Tambrands, Inc., 107 F.3d 737, 740-742 (9th Cir. 1997)).

XII. 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 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.

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.

XIV. 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.

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XV. References

    The following references have been placed on display in the 
Division of Dockets Management (see ADDRESSES) and may be seen by 
interested persons between 9 a.m. and 4 p.m., Monday through Friday.

1. Gregoratos G., Cheitlin, M.D., Conill A., et al., ``ACC/AHA 
Guidelines for Implantation of Cardiac Pacemakers and Antiarrhythmia 
Devices: Executive Summary--A Report of the American College of 
Cardiology/American Heart Association Task Force on Practice 
Guidelines (Committee on Pacemaker Implantation),'' Circulation 
1998; 97; 1325-35.
    2. Class II Special Controls Guidance Document: External 
Pacemaker Pulse Generator.

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 870.3600 is amended by revising paragraph (b) and 
removing paragraph (c) to read as follows:


Sec.  870.3600  External pacemaker pulse generator.

* * * * *
    (b) Classification. Class II. The special control for this device 
is the FDA guidance document entitled ``Class II Special Controls 
Guidance Document: External Pacemaker Pulse Generator.''

    Dated: October 11, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2011-26625 Filed 10-13-11; 8:45 am]
BILLING CODE 4160-01-P