[Federal Register: December 18, 2003 (Volume 68, Number 243)]
[Rules and Regulations]
[Page 70435-70436]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr18de03-9]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
21 CFR Part 882
[Docket No. 2002N-0370]
Neurological Devices; Classification of Human Dura Mater
AGENCY: Food and Drug Administration, HHS.
ACTION: Final rule.
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SUMMARY: The Food and Drug Administration (FDA) is classifying human
dura mater intended to repair defects in human dura mater into class II
(special controls). This action is being taken to establish sufficient
regulatory control to provide reasonable assurance of the safety and
effectiveness of the device. Elsewhere in this issue of the Federal
Register, FDA is announcing the availability of a guidance document
entitled ``Class II Special Controls Guidance Document: Human Dura
Mater'' that will serve as the special control for this device.
Dates: This rule is effective January 20, 2004.
FOR FURTHER INFORMATION CONTACT: Charles N. Durfor, Center for Devices
and Radiological Health (HFZ-410), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-3090.
SUPPLEMENTARY INFORMATION:
I. Background
In the Federal Register of October 22, 2002 (67 FR 64835), FDA
issued a proposed rule to classify human dura mater into class II based
on new information regarding this device and the recommendation of the
Neurological Devices Panel. FDA identified the draft guidance document
entitled ``Class II Special Controls Guidance Document: Human Dura
Mater; Guidance for Industry and FDA'' as the proposed special control
capable of providing reasonable assurance of the safety and
effectiveness of the device. The device is intended to repair defects
in human dura mater. FDA invited interested persons to comment on the
proposed rule by January 21, 2003. FDA received one comment.
II. Summary of the Comment and FDA's Response
The comment did not express an opinion on the proposed rule. It
informed FDA of new research in transgenic mice which suggests that it
may be difficult to distinguish whether a patient's cause of death is
related to Creutzfeldt-Jakob Disease (CJD) or variant CJD based on
neuropathology. FDA appreciates receipt of the information but does not
believe it affects the classification of human dura mater. The guidance
document ``Class II Special Controls Guidance Document: Human Dura
Mater'' recommends clinical and histopathological methods, including
next of kin interviews and full brain autopsy, respectively, that are
intended to identify and defer potential human dura mater donors who
have either CJD or variant CJD.
III. FDA's Conclusion
Based on a review of the available information in the preamble to
the proposed rule and placed on file in FDA's Division of Dockets
Management (HFA-305), Food and Drug Administration, 5600 Fishers Lane,
rm. 1061, Rockville, MD 20852, FDA concludes that special controls, in
conjunction with general controls, provide reasonable assurance of the
safety and effectiveness of this device.
[[Page 70436]]
Elsewhere in this issue of the Federal Register, FDA is announcing the
availability of the class II special controls guidance document.
Following the effective date of this final classification rule, any
firm submitting a premarket notification (510(k)) for human dura mater
will need to address the issues covered in the class II special control
guidance. However, the firm need only show that its device meets the
recommendations of the guidance or in some other way provides
equivalent assurances of safety and effectiveness.
FDA is now codifying the classification and the class II special
control guidance document for human dura mater by adding Sec. 882.5975
to the device regulations in Title 21, Code of Federal Regulations (21
CFR). For the convenience of the reader, FDA is also adding Sec.
882.1(e) to inform the reader where to find guidance documents
referenced in 21 CFR part 882.
As discussed in the preamble to the proposed rule (67 FR 64835),
FDA intends to transfer the regulation of human dura mater from the
Center for Devices and Radiological Health to the Center for Biologics
Evaluation and Research. FDA expects this transfer will take place upon
the implementation of human-cellular and tissue-based product
regulations, including regulations addressing donor suitability, good
tissue practices, and registration and listing. FDA has initiated
rulemaking proceedings involving these products. (See 64 FR 52696,
September 30, 1999; 66 FR 1507, January 8, 2001; and 66 FR 5447,
January 19, 2001.) In the interim, FDA believes that regulation of dura
mater as a class II device subject to general and special controls
provides a reasonable assurance of its safety and effectiveness.
IV. Environmental Impact
The agency has determined under 21 CFR 25.34(b) 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 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 rule is consistent with the regulatory philosophy and principles
identified in the Executive order. In addition, the final rule is not a
significant regulatory action as defined by the Executive order and so
is not subject to review under the Executive order.
FDA has also examined the impact of the rule under the Regulatory
Flexibility Act. The purpose of this rule is to change the
classification of human dura mater from an unclassified medical device
into a class II medical device subject to special controls. As an
unclassified device, this device is already subject to premarket
notification and the general labeling provisions of the act. There are
currently five to seven manufacturers of human dura mater medical
devices. All of the firms meet the Small Business Administration's
definition of a small entity (fewer than 500 employees). FDA, however,
believes that manufacturers presently marketing this device already
conform with many of the recommendations in the special controls
guidance document. New manufacturers of human dura mater will only need
to submit 510(k)s, as the statute now requires them to do, and
demonstrate that they meet the recommendations of the guidance or in
some way provide equivalent assurances of safety and effectiveness. In
addition, biocompatibility and structural testing recommendations are
eliminated from the guidance, which will decrease the premarket
notification costs for manufacturers introducing new human dura mater
devices into commercial distribution. The agency, therefore, certifies
that this rule will not have a significant economic impact on a
substantial number of small entities. In addition, this rule will not
impose costs of $100 million or more on either the private sector or
State, local, and tribal governments in the aggregate, and therefore, a
summary statement or analysis under section 202(a) of the Unfunded
Mandates Reform Act of 1995 is not required.
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 does not contain information collection provisions
that are subject to review by the Office of Management and Budget under
the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520).
List of Subjects in 21 CFR Part 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 part
882 is amended as follows:
PART 882--NEUROLOGICAL DEVICES
0
1. 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
2. Section 882.1 is amended by adding paragraph (e) to read as follows:
Sec. 882.1 Scope.
* * * * *
(e) Guidance documents referenced in this part are available on the
Internet at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh/guidance.html.
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3. Section 882.5975 is added to subpart F to read as follows:
Sec. 882.5975 Human dura mater.
(a) Identification. Human dura mater is human pachymeninx tissue
intended to repair defects in human dura mater.
(b) Classification. Class II (special controls). The special
control for this device is the FDA guidance document entitled ``Class
II Special Controls Guidance Document: Human Dura Mater.'' See Sec.
882.1(e) for the availability of this guidance.
Dated: December 5, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-31174 Filed 12-17-03; 8:45 am]
BILLING CODE 4160-01-S