[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Generator Devices; Draft Guidance for Industry and Food and Drug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
[[Page 64226]]
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