Effective Date of Requirement for Premarket Approval for Three Class III Preamendments Devices, 50663-50667 [2011-20664]
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50663
Rules and Regulations
Federal Register
Vol. 76, No. 158
Tuesday, August 16, 2011
This section of the FEDERAL REGISTER
contains regulatory documents having general
applicability and legal effect, most of which
are keyed to and codified in the Code of
Federal Regulations, which is published under
50 titles pursuant to 44 U.S.C. 1510.
The Code of Federal Regulations is sold by
the Superintendent of Documents. Prices of
new books are listed in the first FEDERAL
REGISTER issue of each week.
Accordingly, 18 CFR part 292 is
corrected by making the following
correcting amendment:
Subchapter K—Regulations Under The
Public Utility Regulatory Policies Act of
1978
PART 292—REGULATIONS UNDER
SECTION 201 AND 210 OF THE
PUBLIC UTILITY REGULATORY
POLICIES ACT OF 1978 WITH REGARD
TO SMALL POWER PRODUCTION AND
COGENERATION
DEPARTMENT OF ENERGY
Federal Energy Regulatory
Commission
■
18 CFR Part 292
Authority: 16 U.S.C. 791a–825r, 2601–
2645; 31 U.S.C. 9701; 42 U.S.C. 7101–7352.
1. The authority citation for part 292
continues to read as follows:
[Docket No. RM09–23–000]
2. Section 292.205 is amended by
adding paragraphs (d)(1) through (5) to
read as follows:
■
Revisions to Form, Procedures and
Criteria for Certification of Qualifying
Facility Status for a Small Power
Production or Cogeneration Facility
Federal Energy Regulatory
Commission.
ACTION: Correcting amendment.
AGENCY:
This document contains
corrections to final regulations which
were published in the Federal Register
of Tuesday, March 30, 2010. The final
rule document adopted revisions to
FERC Form 556 and to Commission
procedures and criteria for the
certification of qualifying facility status
for a small power production or
cogeneration facility.
DATES: August 16, 2011.
FOR FURTHER INFORMATION CONTACT: S.L.
Higginbottom (Legal Information),
Office of the General Counsel, Federal
Energy Regulatory Commission, 888
First Street, NE., Washington, DC 20426,
Telephone: 202–502–8561, E-mail:
samuel.higginbottom@ferc.gov.
SUPPLEMENTARY INFORMATION: The final
regulations amended 18 CFR 292.205
and affect the Commission’s criteria and
procedures for the certification of
qualifying facility status for small power
production or cogeneration facilities.
As published, the final regulations
contained errors; they incorrectly
removed paragraphs from 18 CFR
292.205(d). These paragraphs contain
critical criteria for new cogeneration
facilities.
jlentini on DSK4TPTVN1PROD with RULES
List of Subjects in 18 CFR Part 292
Electric power, Electric power plants,
Electric utilities.
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Dated: August 9, 2011.
Kimberly D. Bose,
Secretary.
[FR Doc. 2011–20751 Filed 8–15–11; 8:45 am]
BILLING CODE 6717–01–P
§ 292.205 Criteria for qualifying
cogeneration facilities.
*
SUMMARY:
efficiency, economic, and variable
thermal energy requirements.
(4) For purposes of paragraphs (d)(1)
and (2) of this section, a new
cogeneration facility of 5 MW or smaller
will be presumed to satisfy the
requirements of those paragraphs.
(5) For purposes of paragraph (d)(1) of
this section, where a thermal host
existed prior to the development of a
new cogeneration facility whose thermal
output will supplant the thermal source
previously in use by the thermal host,
the thermal output of such new
cogeneration facility will be presumed
to satisfy the requirements of paragraph
(d)(1).
*
*
*
*
(d) * * *
(1) The thermal energy output of the
cogeneration facility is used in a
productive and beneficial manner; and
(2) The electrical, thermal, chemical
and mechanical output of the
cogeneration facility is used
fundamentally for industrial,
commercial, residential or institutional
purposes and is not intended
fundamentality for sale to an electric
utility, taking into account
technological, efficiency, economic, and
variable thermal energy requirements, as
well as state laws applicable to sales of
electric energy from a qualifying facility
to its host facility.
(3) Fundamental use test. For the
purpose of satisfying paragraph (d)(2) of
this section, the electrical, thermal,
chemical and mechanical output of the
cogeneration facility will be considered
used fundamentally for industrial,
commercial, or institutional purposes,
and not intended fundamentally for sale
to an electric utility if at least 50 percent
of the aggregate of such output, on an
annual basis, is used for industrial,
commercial, residential or institutional
purposes. In addition, applicants for
facilities that do not meet this safe
harbor standard may present evidence
to the Commission that the facilities
should nevertheless be certified given
state laws applicable to sales of electric
energy or unique technological,
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DEPARTMENT OF HEALTH AND
HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 870 and 884
[Docket No. FDA–2010–N–0412]
Effective Date of Requirement for
Premarket Approval for Three Class III
Preamendments Devices
AGENCY:
Food and Drug Administration,
HHS.
ACTION:
Final rule.
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 the following three
class III preamendments devices:
Ventricular bypass (assist) device;
pacemaker repair or replacement
material; and female condom. The
Agency has summarized its findings
regarding the degree of risk of illness or
injury designed to be eliminated or
reduced by requiring the devices 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.
SUMMARY:
DATES:
This rule is effective August 23,
2011.
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Federal Register / Vol. 76, No. 158 / Tuesday, August 16, 2011 / Rules and Regulations
FOR FURTHER INFORMATION CONTACT:
jlentini on DSK4TPTVN1PROD with RULES
Michael Ryan, Center for Devices and
Radiological Health, Food and Drug
Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1615, Silver Spring,
MD 20993–0002, 301–796–6283.
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
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
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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) established 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
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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
since 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
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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. FDA divided this
universe of devices into three groups as
referenced in the May 6, 1994, notice.
In the Federal Register of August 25,
2010 (75 FR 52294) (the August 25,
2010, 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 four premendments class III devices:
Ventricular (bypass) assist device;
pacemaker repair or replacement
material; female condom; and
transilluminator for breast evaluation. In
accordance with section 515(b)(2)(A) of
the FD&C Act, FDA included in the
preamble of the proposal 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 device to meet the
premarket approval requirements of the
FD&C Act, and the benefits to the public
from use of the device. The August 25,
2010, 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
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the classification of the device based on
new information relevant to its
classification. Any petition requesting a
change in classification of the devices
was required to be submitted by
September 9, 2010. The comment period
closed November 23, 2010.
FDA received no comments on the
proposed rule. FDA received one
petition requesting a change in the
classification of the transilluminator for
breast evaluation. FDA has yet to
resolve the request; therefore, the
transilluminator for breast evaluation is
not subject to this final rule.
II. Findings With Respect to Risks and
Benefits
Under section 515(b)(3) of the FD&C
Act, FDA is adopting its findings as
published in the August 25, 2010,
proposed rule with the exception of the
findings related to the transilluminator
for breast evaluation. 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 these devices have an
approved PMA or a declared completed
PDP and (2) the benefits to the public
from the use of the devices.
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, (74 FR 16214, April
9, 2009), and any additional information
that FDA has encountered. Additional
information regarding the risks as well
as classification associated with these
device types can be found in the
following proposed and final rules
published in the Federal Register on
these dates: Cardiovascular Devices—
part 870 (21 CFR part 870) (44 FR
13284, March 9, 1979 and 45 FR 7904,
February 5, 1980, 52 FR 17732 at 17736,
May 11, 1987); and Obstetrical and
Gynecological Devices—part 884 (21
CFR part 884) (64 FR 31164, June 10,
1999, and 65 FR 31454, May 18, 2000).
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 with the exception of the
findings related to the transilluminator
for breast evaluation. FDA is issuing this
final rule to require premarket approval
of these generic types of devices for
class III preamendments devices by
revising parts 870 and 884.
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
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50665
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 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
will be required to 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. Because there have been no
premarket submissions for these devices
in the past 5 years and all of the affected
devices have fallen into disuse, FDA has
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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 $136
million, using the most current (2010)
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 registration and listing and other data
for the affected devices. Two of the
devices affected by this final rule, the
female condom and ventricular bypass
device, have never appeared in FDA’s
electronic registration and listing
database. These devices were identified
as preamendment devices, but since
their classification, the Agency has no
record of them ever being marketed. In
addition, these devices represent older
technologies that have since been
replaced by newer technologies
currently being marketed under a PMA.
The final affected device, pacemaker
repair and replacement material, is a
material that can be used in multiple
devices that was last listed in 2001, and
the Agency is aware of no evidence that
the device has been marketed since
1991. In addition, on the increasingly
rare occasions when a pacemaker is
repaired today, the repair is done with
materials specific to the approved
device. This information is summarized
in table 1 of this document as follows.
TABLE 1—SUMMARY OF ELECTRONIC REGISTRATION AND LISTING INFORMATION
Device name
Product code
510(k) or
PMA?
Last listed
Last marketed
Female Condom ............................................
Ventricular Bypass Device .............................
Pacemaker Repair and Replacement ...........
OBY ............
OKR ............
KFJ ..............
No ................
No ...............
No ................
Never Listed ..............
Never Listed ..............
2001 ..........................
1930s .........................
No Record .................
1991 ..........................
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 will 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.
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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 21 CFR
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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 Parts 870 and
884
Medical devices.
Therefore, under the Federal Food,
Drug, and Cosmetic Act and under
authority delegated to the Commissioner
of Food and Drugs, 21 CFR parts 870
and 884 are 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 870.3545 is amended by
revising paragraph (c) to read as follows:
■
§ 870.3545
device.
Ventricular bypass (assist)
*
*
*
*
*
(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 November
21, 2011, for any ventricular bypass
(assist) device that was in commercial
distribution before May 28, 1976, or that
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Replaced by
approved
technology?
Yes.
Yes.
Yes.
has, on or before November 21, 2011,
been found to be substantially
equivalent to any ventricular bypass
(assist) device that was in commercial
distribution before May 28, 1976. Any
other ventricular bypass (assist) device
shall have an approved PMA or
declared completed PDP in effect before
being placed in commercial
distribution.
3. Section 870.3710 is amended by
revising paragraph (c) to read as follows:
■
§ 870.3710 Pacemaker repair or
replacement material.
*
*
*
*
*
(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 November
21, 2011, for any pacemaker repair or
replacement material device that was in
commercial distribution before May 28,
1976, or that has, on or before November
21, 2011, been found to be substantially
equivalent to any pacemaker repair or
replacement material device that was in
commercial distribution before May 28,
1976. Any other pacemaker repair or
replacement material device shall have
an approved PMA or declared
completed PDP in effect before being
placed in commercial distribution.
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September 5, 2011. This rule will be
enforced with actual notice from 7 a.m.
on August 5, 2011 until 5 p.m. on
September 5, 2011.
PART 884—OBSTETRICAL AND
GYNECOLOGICAL DEVICES
4. The authority citation for 21 CFR
part 884 continues to read as follows:
■
Authority: 21 U.S.C. 351, 360, 360c, 360e,
360j, 371.
5. Section 884.5330 is amended by
revising paragraph (c) to read as follows:
■
§ 884.5330
Female condom.
*
*
*
*
*
(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 November
21, 2011, for any female condom that
was in commercial distribution before
May 28, 1976, or that has, on or before
November 21, 2011, been found to be
substantially equivalent to any female
condom that was in commercial
distribution before May 28, 1976. Any
other female condom shall have an
approved PMA or declared completed
PDP in effect before being placed in
commercial distribution.
Dated: August 10, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices
and Radiological Health.
[FR Doc. 2011–20664 Filed 8–15–11; 8:45 am]
BILLING CODE 4160–01–P
Documents indicated in this
preamble as being available in the
docket are part of docket USCG–2011–
0708 and are available online by going
to https://www.regulations.gov, inserting
USCG–2011–0708 in the ‘‘Keyword’’
box, and then clicking ‘‘Search.’’ They
are also available for inspection or
copying at the Docket Management
Facility (M–30), U.S. Department of
Transportation, West Building Ground
Floor, Room W12–140, 1200 New Jersey
Avenue, SE., Washington, DC 20590,
between 9 a.m. and 5 p.m., Monday
through Friday, except Federal holidays.
ADDRESSES:
If
you have questions on this temporary
rule, call or e-mail Lieutenant Junior
Grade Terence Leahy, Waterways
Management Division at Coast Guard
Sector Northern New England,
telephone 207–767–0398, e-mail
Terence.O.Leahy@uscg.mil or
Lieutenant Junior Grade Isaac Slavitt,
Waterways Management Division at
Coast Guard First District, telephone
617–223–8385. If you have questions on
viewing the docket, call Renee V.
Wright, Program Manager, Docket
Operations, telephone 202–366–9826.
FOR FURTHER INFORMATION CONTACT:
SUPPLEMENTARY INFORMATION:
Regulatory Information
DEPARTMENT OF HOMELAND
SECURITY
Coast Guard
33 CFR Part 165
[Docket No. USCG–2011–0708]
RIN 1625–AA11
Regulated Navigation Area;
Portsmouth Naval Shipyard,
Portsmouth, NH
Coast Guard, DHS.
Temporary final rule.
AGENCY:
ACTION:
The Coast Guard is
establishing a regulated navigation area
on the Piscataqua River near
Portsmouth, NH. This temporary final
rule places speed restrictions on all
vessels transiting the navigable waters
on the Piscataqua River, Portsmouth,
NH near the Portsmouth Naval Shipyard
between Henderson Point Light on
Seavey Island and Badgers Island Buoy
14. This rule is necessary to provide for
the safety of life on the navigable waters
during ongoing ship construction.
DATES: This rule is effective from
August 16, 2011 until 5 p.m. on
jlentini on DSK4TPTVN1PROD with RULES
SUMMARY:
VerDate Mar<15>2010
11:12 Aug 15, 2011
Jkt 223001
The Coast Guard is issuing this
temporary final rule without prior
notice and opportunity to comment
pursuant to authority under section 4(a)
of the Administrative Procedure Act
(APA) (5 U.S.C. 553(b)). This provision
authorizes an agency to issue a rule
without prior notice and opportunity to
comment when the agency for good
cause finds that those procedures are
‘‘impracticable, unnecessary, or contrary
to the public interest.’’ Under 5 U.S.C.
553(b)(B), the Coast Guard finds that
good cause exists for not publishing a
notice of proposed rulemaking (NPRM)
with respect to this rule because the
Coast Guard was not notified of the
need for this rule until 13 July 2011, and
the Portsmouth Naval Facility will begin
diving operations in this area within a
short timeframe making publication of a
NPRM and Final Rule impractical. This
regulated navigation area is necessary to
provide for the safety of the divers and
others working in the area as wake from
passing vessels could cause the ship to
move erratically and unexpectedly,
injuring the divers and their support
crews. Not providing for the safety of
the divers and others in the area is
PO 00000
Frm 00005
Fmt 4700
Sfmt 4700
50667
contrary to the public interest of
creating a safe work environment.
Under 5 U.S.C. 553(d)(3), the Coast
Guard finds that good cause exists for
making this rule effective less than 30
days after publication in the Federal
Register as immediate action is
necessary to provide for the safety of
divers and workers on the vessel. In
addition to the reasons stated within
this preamble, a delay in the effective
date of this rule is contrary to the
public’s interest in ensuring the ship
construction project continues as
scheduled.
Basis and Purpose
Under the Ports and Waterways Safety
Act, the Coast Guard has the authority
to establish RNAs in defined water areas
that are determined to have hazardous
conditions and in which vessel traffic
can be regulated in the interest of safety.
See 33 U.S.C. 1231 and Department of
Homeland Security Delegation No.
0170.1.
As part of ongoing ship construction
projects at the Portsmouth Naval
Shipyard, divers will be working on the
hull of a vessel for approximately four
weeks beginning on August 5, 2011.
Unexpected and uncontrolled
movement of the vessel due to wake
while divers are in the water creates a
significant risk of serious injury or
death. In order to ensure the safety of
vessel workers such as divers during the
period of ship construction work, the
Coast Guard is creating a regulated
navigation area to limit the speed, and
thus wake, of all vessels operating in the
vicinity of the shipyard.
Discussion of Rule
This action places speed restrictions
on all vessels transiting the navigable
waters on the Piscataqua River,
Portsmouth, NH near the Portsmouth
Naval Shipyard between Henderson
Point Light on Seavey Island and
Badgers Island Buoy 14 when necessary
for the safety of navigation during
periods of ship construction work. All
vessels operating in this area shall
proceed with caution; operate at no
more than 5 knots and in a manner so
as to produce no wake. Diving
operations and other vessel construction
may occur at any time, day or night.
The Captain of the Port Sector
Northern New England will cause notice
of enforcement or suspension of
enforcement of this regulated navigation
area to be made by all appropriate
means in order to affect the widest
distribution among the affected
segments of the public. Such means of
notification will include, but is not
limited to, Broadcast Notice to Mariners
E:\FR\FM\16AUR1.SGM
16AUR1
Agencies
[Federal Register Volume 76, Number 158 (Tuesday, August 16, 2011)]
[Rules and Regulations]
[Pages 50663-50667]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2011-20664]
=======================================================================
-----------------------------------------------------------------------
DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 870 and 884
[Docket No. FDA-2010-N-0412]
Effective Date of Requirement for Premarket Approval for Three
Class III Preamendments Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
-----------------------------------------------------------------------
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 the
following three class III preamendments devices: Ventricular bypass
(assist) device; pacemaker repair or replacement material; and female
condom. The Agency has summarized its findings regarding the degree of
risk of illness or injury designed to be eliminated or reduced by
requiring the devices 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 August 23, 2011.
[[Page 50664]]
FOR FURTHER INFORMATION CONTACT: Michael Ryan, Center for Devices and
Radiological Health, Food and Drug Administration, 10903 New Hampshire
Ave., Bldg. 66, rm. 1615, Silver Spring, MD 20993-0002, 301-796-6283.
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 devices), are classified after
FDA has: (1) Received a recommendation from a device classification
panel (an FDA advisory committee); (2) published the panel's
recommendation for comment, along with a proposed regulation
classifying the device; and (3) published a final regulation
classifying the device. FDA has classified most preamendments devices
under these procedures.
Devices that were not in commercial distribution prior to May 28,
1976 (generally referred to as postamendments devices) are
automatically classified by section 513(f) of the FD&C Act into class
III without any FDA rulemaking process. Those devices remain in class
III and require premarket approval unless, and until, the device is
reclassified into class I or II or FDA issues an order finding the
device to be substantially equivalent, in accordance with section
513(i) of the FD&C Act, to a predicate device that does not require
premarket approval. The Agency determines whether new devices are
substantially equivalent to predicate devices by means of premarket
notification procedures in section 510(k) of the FD&C Act (21 U.S.C.
360(k)) and 21 CFR part 807.
A preamendments device that has been classified into class III may
be marketed by means of premarket notification procedures (510(k)
process) without submission of a PMA until FDA issues a final
regulation under section 515(b) of the FD&C Act (21 U.S.C. 360e(b))
requiring premarket approval. Section 515(b)(1) established 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 since 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
[[Page 50665]]
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. FDA divided this universe of devices into
three groups as referenced in the May 6, 1994, notice.
In the Federal Register of August 25, 2010 (75 FR 52294) (the
August 25, 2010, 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 four premendments class III devices:
Ventricular (bypass) assist device; pacemaker repair or replacement
material; female condom; and transilluminator for breast evaluation. In
accordance with section 515(b)(2)(A) of the FD&C Act, FDA included in
the preamble of the proposal 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 device to meet the premarket
approval requirements of the FD&C Act, and the benefits to the public
from use of the device. The August 25, 2010, 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 device based on new
information relevant to its classification. Any petition requesting a
change in classification of the devices was required to be submitted by
September 9, 2010. The comment period closed November 23, 2010.
FDA received no comments on the proposed rule. FDA received one
petition requesting a change in the classification of the
transilluminator for breast evaluation. FDA has yet to resolve the
request; therefore, the transilluminator for breast evaluation is not
subject to this final rule.
II. Findings With Respect to Risks and Benefits
Under section 515(b)(3) of the FD&C Act, FDA is adopting its
findings as published in the August 25, 2010, proposed rule with the
exception of the findings related to the transilluminator for breast
evaluation. 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 these
devices have an approved PMA or a declared completed PDP and (2) the
benefits to the public from the use of the devices.
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, (74
FR 16214, April 9, 2009), and any additional information that FDA has
encountered. Additional information regarding the risks as well as
classification associated with these device types can be found in the
following proposed and final rules published in the Federal Register on
these dates: Cardiovascular Devices--part 870 (21 CFR part 870) (44 FR
13284, March 9, 1979 and 45 FR 7904, February 5, 1980, 52 FR 17732 at
17736, May 11, 1987); and Obstetrical and Gynecological Devices--part
884 (21 CFR part 884) (64 FR 31164, June 10, 1999, and 65 FR 31454, May
18, 2000).
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 with the
exception of the findings related to the transilluminator for breast
evaluation. FDA is issuing this final rule to require premarket
approval of these generic types of devices for class III preamendments
devices by revising parts 870 and 884.
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 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 will be required to 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. Because there have been no premarket submissions for
these devices in the past 5 years and all of the affected devices have
fallen into disuse, FDA has
[[Page 50666]]
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 $136 million, using the most current (2010) 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 registration and
listing and other data for the affected devices. Two of the devices
affected by this final rule, the female condom and ventricular bypass
device, have never appeared in FDA's electronic registration and
listing database. These devices were identified as preamendment
devices, but since their classification, the Agency has no record of
them ever being marketed. In addition, these devices represent older
technologies that have since been replaced by newer technologies
currently being marketed under a PMA.
The final affected device, pacemaker repair and replacement
material, is a material that can be used in multiple devices that was
last listed in 2001, and the Agency is aware of no evidence that the
device has been marketed since 1991. In addition, on the increasingly
rare occasions when a pacemaker is repaired today, the repair is done
with materials specific to the approved device. This information is
summarized in table 1 of this document as follows.
Table 1--Summary of Electronic Registration and Listing Information
--------------------------------------------------------------------------------------------------------------------------------------------------------
Replaced by approved
Device name Product code 510(k) or PMA? Last listed Last marketed technology?
--------------------------------------------------------------------------------------------------------------------------------------------------------
Female Condom..................... OBY................... No................... Never Listed........ 1930s............... Yes.
Ventricular Bypass Device......... OKR................... No................... Never Listed........ No Record........... Yes.
Pacemaker Repair and Replacement.. KFJ................... No................... 2001................ 1991................ Yes.
--------------------------------------------------------------------------------------------------------------------------------------------------------
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 will
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 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 Parts 870 and 884
Medical devices.
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
870 and 884 are 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 870.3545 is amended by revising paragraph (c) to read as
follows:
Sec. 870.3545 Ventricular bypass (assist) device.
* * * * *
(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 November 21, 2011, for any ventricular
bypass (assist) device that was in commercial distribution before May
28, 1976, or that has, on or before November 21, 2011, been found to be
substantially equivalent to any ventricular bypass (assist) device that
was in commercial distribution before May 28, 1976. Any other
ventricular bypass (assist) device shall have an approved PMA or
declared completed PDP in effect before being placed in commercial
distribution.
0
3. Section 870.3710 is amended by revising paragraph (c) to read as
follows:
Sec. 870.3710 Pacemaker repair or replacement material.
* * * * *
(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 November 21, 2011, for any pacemaker
repair or replacement material device that was in commercial
distribution before May 28, 1976, or that has, on or before November
21, 2011, been found to be substantially equivalent to any pacemaker
repair or replacement material device that was in commercial
distribution before May 28, 1976. Any other pacemaker repair or
replacement material device shall have an approved PMA or declared
completed PDP in effect before being placed in commercial distribution.
[[Page 50667]]
PART 884--OBSTETRICAL AND GYNECOLOGICAL DEVICES
0
4. The authority citation for 21 CFR part 884 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
5. Section 884.5330 is amended by revising paragraph (c) to read as
follows:
Sec. 884.5330 Female condom.
* * * * *
(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 November 21, 2011, for any female
condom that was in commercial distribution before May 28, 1976, or that
has, on or before November 21, 2011, been found to be substantially
equivalent to any female condom that was in commercial distribution
before May 28, 1976. Any other female condom shall have an approved PMA
or declared completed PDP in effect before being placed in commercial
distribution.
Dated: August 10, 2011.
Nancy K. Stade,
Deputy Director for Policy, Center for Devices and Radiological
Health.
[FR Doc. 2011-20664 Filed 8-15-11; 8:45 am]
BILLING CODE 4160-01-P