[Federal Register Volume 68, Number 243 (Thursday, December 18, 2003)]
[Rules and Regulations]
[Pages 70435-70436]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-31174]


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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 FDA identified the draft guidance document 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://www.fda.gov/cdrh/guidance.html.

0
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