[Federal Register: June 23, 2004 (Volume 69, Number 120)]
[Rules and Regulations]
[Page 34917-34920]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr23jn04-7]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Parts 868, 870, and 882
[Docket No. 2003N-0468]
Medical Devices; Effective Date of Requirement for Premarket
Approval for Three Class III Preamendments Devices
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is requiring 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: Indwelling blood oxyhemoglobin concentration
analyzer, cardiopulmonary bypass pulsatile flow generator, and the
ocular plethysmograph. The agency also is summarizing its proposed
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 June 23, 2004. Under the final rule, a
PMA or a notice of completion of a PDP is required to be filed on or
before September 21, 2004, for any indwelling blood oxyhemoglobin
concentration analyzer, cardiopulmonary bypass pulsatile flow
generator, or ocular plethysmograph that was in commercial
[[Page 34918]]
distribution before May 28, 1976, or that has been found by FDA to be
substantially equivalent to such a device on or before September 21,
2004.
FOR FURTHER INFORMATION CONTACT: Joseph M. Sheehan, Center for Devices
and Radiological Health (HFZ-215), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-827-2974.
SUPPLEMENTARY INFORMATION:
I. Background--Regulatory Authorities
The Federal Food, Drug, and Cosmetic Act (the act), as amended by
the Medical Device Amendments of 1976 (the 1976 amendments) (Public Law
94-295) and the Safe Medical Devices Act of 1990 (the SMDA) (Public Law
101-629), established a comprehensive system for the regulation of
medical devices intended for human use. Section 513 of the 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).
Section 515(b)(1) of the act (21 U.S.C. 360e(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 act,
whichever is later. Also, a preamendments device subject to the
rulemaking procedure under section 515(b) of the act 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.
When a rule to require premarket approval for a preamendments
device is finalized, section 501(f)(2)(B) of the 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 act, whichever is later. If a PMA or notice of
completion of a PDP is not filed by the later of the two dates,
commercial distribution of the device is required to cease.
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 later 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 act, and subject to seizure and condemnation under
section 304 of the 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 act (21 U.S.C. 332), and the
individuals responsible for such shipment will be subject to
prosecution under section 303 of the 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 devices that are the
subjects of this regulation.
The act does not permit an extension of the 90-day period after
issuance of a final rule within which an application or a 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)).
In the Federal Register of November 18, 2003 (68 FR 65014) (the
November 18, 2003, proposed rule), FDA issued a proposed rule to
require the filing of a PMA or a notice of completion of a PDP for the
indwelling blood oxyhemoglobin concentration analyzer, the
cardiopulmonary bypass pulsatile flow generator, and the ocular
plethysmograph. In accordance with section 515(b)(2)(A) of the act, FDA
included in the preamble to the proposed rule the agency's proposed
findings regarding the degree of risk of illness or injury intended to
be eliminated or reduced by requiring the device to meet the statute's
approval requirements as well as the benefits to the public from use of
the device.
The November 18, 2003, proposed rule also provided an opportunity
for interested persons to submit comments on the proposed rule and the
agency's proposed findings. In accordance with section 515(b)(2)(A) of
the act, FDA also 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 the classification of these devices was required to be
submitted by December 3, 2003. The comment period closed February 17,
2004.
FDA received no petitions requesting a change in the classification
of any of the three devices. One comment was addressed to the docket of
the proposed rule. This comment inquired as to when FDA would approve a
certain device that was not one of the devices that were the subject of
the November 18, 2003, proposed rule. The comment was irrelevant and
FDA addressed it outside of the rulemaking process.
II. Devices Subject to This Proposal
A. Indwelling Blood Oxyhemoglobin Concentration Analyzer (21 CFR
868.1120)
An indwelling blood oxyhemoglobin concentration analyzer is a photo
electric device used to measure, in vivo, the oxygen carrying capacity
of hemoglobin in blood to aid in determining the patient's
physiological status.
B. Cardiopulmonary Bypass Pulsatile Flow Generator (21 CFR 870.4320)
A cardiopulmonary bypass pulsatile flow generator is an
electrically and pneumatically operated device used to create pulsatile
blood flow. The device is placed in a cardiopulmonary bypass circuit
downstream from the oxygenator.
C. Ocular Plethysmograph (21 CFR 882.1790)
An ocular plethysmograph is a device used to measure or detect
volume changes in the eye produced by pulsations of the artery, to
diagnose carotid artery occlusive disease (restrictions on blood flow
in the carotid artery).
III. Findings With Respect to Risks and Benefits
Under section 515(b)(3) of the act, FDA is adopting the findings as
published in the November 18, 2003, proposed rule. As required by
section 515(b) of the act, FDA published its findings regarding the
following information: (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 device.
These findings are based on the reports and recommendations of the
[[Page 34919]]
advisory committees (panels) for the classification of these devices
along with any additional information that FDA has discovered.
Additional information can be found in the following proposed and final
rules published in the Federal Register on these dates: Anesthesiology
devices, 21 CFR part 868 (44 FR 63292, November 2, 1979, and 47 FR
31130, July 16, 1982); cardiovascular devices, 21 CFR part 870 (44 FR
13284, March 9, 1979 and 45 FR 7903, February 5, 1980); and
neurological devices, 21 CFR part 882 (43 FR 55639, November 28, 1978,
and 44 FR 51725, September 4, 1979).
IV. The Final Rule
Under section 515(b)(3) of the act, FDA adopts the findings as
published in the preamble of the November 18, 2003, proposed rule and
issues this final rule to require premarket approval of the indwelling
blood oxyhemoglobin concentration analyzer, cardiopulmonary bypass
pulsatile flow generator, and the ocular plethysmograph. This final
rule revises parts 868, 870, and 882 (21 CFR parts 868, 870, and 882).
Under the final rule, a PMA or a notice of completion of a PDP is
required to be filed within 90 days after date of publication of this
rule in the Federal Register (see DATES), for any indwelling blood
oxyhemoglobin concentration analyzer, cardiopulmonary bypass pulsatile
flow generator, or ocular plethysmograph that was 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 that date. If a
PMA or notice of completion of a PDP is filed for any such device
within this time limit, the applicant will be permitted to continue
marketing its device during FDA's review of its submission. Any other
indwelling blood oxyhemoglobin concentration analyzer, cardiopulmonary
bypass pulsatile flow generator, or ocular plethysmograph 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 an indwelling blood
oxyhemoglobin concentration analyzer, cardiopulmonary bypass pulsatile
flow generator, or ocular plethysmograph is not filed on or before 90
days after date of publication of this rule in the Federal Register,
that device is deemed adulterated under section 501(f)(1)(A) of the
act, and commercial distribution of the device must cease immediately.
The device may, however, be distributed for investigational use, if the
requirements of the investigational device exemption (IDE) regulations
(part 812) are met.
The exemptions in Sec. 812.2(c)(1) and (c)(2) from the
requirements of the IDE regulations for preamendments class III devices
cease to apply to any indwelling blood oxyhemoglobin concentration
analyzer, cardiopulmonary bypass pulsatile flow generator, or ocular
plethysmograph that is: (1) Not legally on the market 90 days after
date of publication of this rule in the Federal Register; or (2)
legally on the market by, but for which a PMA or notice of completion
of a PDP is not filed by 90 days after date of publication of this rule
in the Federal Register, or for which PMA approval has been denied or
withdrawn. FDA cautions that manufacturers who are not immediately
planning to submit a PMA or notice of completion of a PDP should submit
IDE applications to FDA by 60 days after date of publication of this
rule in the Federal Register, to minimize the possibility of
interrupting shipment of the device. At this time, FDA is not aware of
any firm that is marketing these devices.
V. PMA Requirements
A PMA for these devices must include the information required by
section 515(c)(1) of the act. Such a PMA should also include a detailed
discussion of the risks identified previously, as well as a discussion
of the effectiveness of the device for which premarket approval is
sought. In addition, a PMA must include all data and information on the
following requirements: (1) Any risks known, or that should be
reasonably known, to the applicant that have not been identified in
this document; (2) the effectiveness of the device that is the subject
of the application; and (3) full reports of all preclinical and
clinical information from investigations on the safety and
effectiveness of the device for which premarket approval is sought.
A PMA should include valid scientific evidence ``obtained from
well-controlled clinical studies, with detailed data,'' in order to
provide reasonable assurance of the safety and effectiveness of the
device for its intended use. (See 21 CFR 860.7(c)(2)).)
Information about the premarket approval process is available from
FDA's Center for Devices and Radiological Health (CDRH) on the Internet
at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/devadvice/pma/.
VI. PDP Requirements
A PDP for any of these devices may be submitted in lieu of a PMA,
and must follow the procedures outlined in section 515(f) of the act. A
PDP should provide the following information: (1) A description of the
device, (2) preclinical trial information (if any), (3) clinical trial
information (if any), (4) a description of the manufacturing and
processing of the devices, (5) the labeling of the device, and (6) all
other relevant information about the device. In addition, the PDP must
include progress reports and records of the trials conducted under the
protocol on the safety and effectiveness of the device for which the
completed PDP is sought.
Information about the PDP process is also available from CDRH on
the on the Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/devadvice/pma/app_methods.html#product_dev
.
VII. 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.
VIII. Analysis of Impacts
FDA has examined the impacts of the final rule under Executive
Order 12866 and the Regulatory Flexibility Act (5 U.S.C. 601-612), and
the Unfunded Mandates Reform Act of 1995 (Public Law 104-4). Executive
Order 12866 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 the
Executive order.
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 because FDA is not aware of any
firms marketing these devices, the agency has concluded that there is
little or no interest in marketing these devices. The agency,
therefore, 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
[[Page 34920]]
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 $110
million. FDA does not expect this final rule to result in any 1-year
expenditure that would meet or exceed this amount.
IX. Paperwork Reduction Act of 1995
This final rule contains information collection provisions that are
subject to review by the Office of Management and Budget (OMB) under
the Paperwork Reduction Act of 1995 (the PRA). The burden hours
required for Sec. 884.5320(c), included in the collection entitled
``Premarket Approval of Medical Devices--21 CFR Part 814,'' are
reported and approved under OMB control number 0910-0231. Therefore,
clearance by OMB under the PRA is not required.
List of Subjects in 21 CFR Parts 868, 870, and 882
Medical devices.
0
Therefore, under the Federal Food, Drug, and Cosmetic Act and under
authority delegated to the Commissioner of Food and Drugs, 21 CFR parts
868, 870, and 882 are amended as follows:
PART 868--ANESTHESIOLOGY DEVICES
0
1. The authority citation for 21 CFR part 868 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
2. Section 868.1120 is amended by revising paragraph (c) to read as
follows:
Sec. 868.1120 Indwelling blood oxyhemoglobin concentration analyzer.
* * * * *
(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 21, 2004, for any indwelling
blood oxyhemoglobin concentration analyzer that was in commercial
distribution before May 28, 1976, or that has, on or before September
21, 2004, been found to be substantially equivalent to an indwelling
blood oxyhemoglobin concentration analyzer that was in commercial
distribution before May 28, 1976. Any other indwelling blood
oxyhemoglobin concentration analyzer shall have an approved PMA or
declared completed PDP in effect before being placed in commercial
distribution.
PART 870--CARDIOVASCULAR DEVICES
0
3. 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
4. Section 870.4320 is amended by revising paragraph (c) to read as
follows:
Sec. 870.4320 Cardiopulmonary bypass pulsatile flow generator.
* * * * *
(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 21, 2004, for any
cardiopulmonary bypass pulsatile flow generator that was in commercial
distribution before May 28, 1976, or that has, on or before September
21, 2004, been found to be substantially equivalent to any
cardiopulmonary bypass pulsatile flow generator that was in commercial
distribution before May 28, 1976. Any other cardiopulmonary bypass
pulsatile flow generator shall have an approved PMA or declared
completed PDP in effect before being placed in commercial distribution.
PART 882--NEUROLOGICAL DEVICES
0
5. The authority citation for 21 CFR part 882 continues to read as
follows:
Authority: 21 U.S.C. 351, 360, 360c, 360e, 360j, 371.
0
6. Section 882.1790 is amended by revising paragraph (c) to read as
follows:
Sec. 882.1790 Ocular plethysmograph.
* * * * *
(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 21, 2004, for any ocular
plethysmograph that was in commercial distribution before May 28, 1976.
Any other ocular plethysmograph shall have an approved PMA or declared
completed PDP in effect before being placed in commercial distribution.
Dated: June 14, 2004.
Jeffrey Shuren,
Assistant Commissioner for Policy.
[FR Doc. 04-14126 Filed 6-22-04; 8:45 am]
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