[Federal Register Volume 77, Number 121 (Friday, June 22, 2012)]
[Rules and Regulations]
[Pages 37570-37573]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-15258]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 870
[Docket No. FDA-2011-N-0526]
Effective Date of Requirement for Premarket Approval for a
Pacemaker Programmer
AGENCY: Food and Drug Administration, HHS.
ACTION: 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
pacemaker programmers. 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 (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 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
[[Page 37571]]
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
establishes the requirement that a preamendments device that FDA has
classified into class III is subject to premarket approval. A
preamendments class III device may be commercially distributed without
an approved PMA or a notice of completion of a PDP until 90 days after
FDA issues a final rule requiring premarket approval for the device, or
30 months after final classification of the device under section 513 of
the FD&C Act, whichever is later. Also, a preamendments device subject
to the rulemaking procedure under section 515(b) of the FD&C Act is not
required to have an approved investigational device exemption (IDE)
(see 21 CFR part 812) contemporaneous with its interstate distribution
until the date identified by FDA in the final rule requiring the
submission of a PMA for the device. At that time, an IDE is required
only if a PMA has not been submitted or a PDP completed.
Section 515(b)(2)(A) of the FD&C Act provides that a proceeding to
issue a final rule to require premarket approval shall be initiated by
publication of a notice of proposed rulemaking containing: (1) The
regulation, (2) proposed findings with respect to the degree of risk of
illness or injury designed to be eliminated or reduced by requiring the
device to have an approved PMA or a declared completed PDP and the
benefit to the public from the use of the device, (3) an opportunity
for the submission of comments on the proposed rule and the proposed
findings, and (4) an opportunity to request a change in the
classification of the device based on new information relevant to the
classification of the device.
Section 515(b)(2)(B) of the FD&C Act provides that if FDA receives
a request for a change in the classification of the device within 15
days of the publication of the notice, FDA shall, within 60 days of the
publication of the notice, consult with the appropriate FDA advisory
committee and publish a notice denying the request for change in
reclassification or announcing its intent to initiate a proceeding to
reclassify the device under section 513(e) of the FD&C Act. Section
515(b)(3) of the FD&C Act provides that FDA shall, after the close of
the comment period on the proposed rule and consideration of any
comments received, issue a final rule to require premarket approval or
publish a document terminating the proceeding together with the reasons
for such termination. If FDA terminates the proceeding, FDA is required
to initiate reclassification of the device under section 513(e) of the
FD&C Act, unless the reason for termination is that the device is a
banned device under section 516 of the FD&C Act (21 U.S.C. 360f).
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) 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 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 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.
In the Federal Register of May 6, 1994 (59 FR 23731), 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.
In the Federal Register of August 4, 2011 (76 FR 47085), 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
pacemaker programmer (the August 2011 proposed rule). In accordance
with section 515(b)(2)(A) of the FD&C Act, FDA included in the preamble
of the August 2011 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 August 2011 proposed rule also provided an
opportunity for
[[Page 37572]]
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
for the pacemaker programmer was required to be submitted by August 19,
2011. The comment period for the pacemaker programmer electrode closed
November 2, 2011.
FDA received one comment on the August 2011 proposed rule for the
pacemaker programmer. 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
August 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 pacemaker programmer 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 7904 at 7945); 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 August 2011 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.
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 this class III
preamendments device 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 these 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. In the August 2011
proposed rule, FDA mistakenly said that the PMAs and PDPs should be
submitted by November 2, 2011. Rather, PMAs and PDPs should be
submitted by September 20, 2012. 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 directs Agencies to assess all
costs and benefits of available regulatory alternatives and, when
regulation is necessary, to select regulatory approaches that maximize
net benefits (including potential economic, environmental, public
health and safety, and other advantages; distributive impacts; and
equity). The Agency believes that this 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 has been only one 510(k) submission assigned
to this product code within the past 15 years. Upon review of this
record, the Agency determined that this was done in error, and the
record has been corrected. Accordingly, it has been determined that all
of the affected devices have fallen into 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
economic impact. We base this determination on an analysis of
registration and listing and other data for the device.
There have been no 510(k) submissions for pacemaker programmers
since 1995 with the exception of one 510(k) submission cleared in 2009
for a Pacing System Analyzer cleared for use with a PMA-approved
programmer. This device was inappropriately reviewed as a 510(k)
submission, because this device should have been regulated under PMA.
Programmers currently marketed are capable of programming all
implantable cardiac devices including pacemakers and defibrillators.
Because these programmers interact with products covered under several
class III product codes including adaptive rate pacemakers (LWP);
implantable defibrillators (LWS); cardiac resynchronization pacemakers
(CRT-P, NKE); and implantable defibrillators (CRT-D, NIK), they have
been entirely reviewed within the PMA program for more than a decade.
This information is summarized in table 1 of this document as
follows.
[[Page 37573]]
Table 1--Summary of Electronic Registration and Listing Information
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Last valid Replaced by approved
Device name Product code Last listed 510(k) cleared technology?
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Pacemaker Programmer............. KRG................. 2012 1995 Yes.\1\
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\1\ Current pacemaker programmers interact with products covered under several class III product codes and have
been entirely reviewed within the PMA program for more than a decade.
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 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.
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 870.3700 is amended by revising paragraphs (a) and (c) to
read as follows:
Sec. 870.3700 Pacemaker programmers.
(a) Identification. A pacemaker programmer is a device used to
noninvasively change one or more of the electrical operating
characteristics of a pacemaker.
* * * * *
(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 pacemaker
programmer 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 pacemaker programmer that was in
commercial distribution before May 28, 1976. Any other pacemaker
programmer shall have an approved PMA or declared completed PDP in
effect before being placed in commercial distribution.
Dated: June 18, 2012.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological Health.
[FR Doc. 2012-15258 Filed 6-21-12; 8:45 am]
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