[Federal Register Volume 64, Number 198 (Thursday, October 14, 1999)]
[Notices]
[Pages 55736-55737]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26720]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 99D-4052]
Medical Devices; Draft Guidance for the Preparation of a
Premarket Notification Application for Processed Human Dura Mater;
Availability
AGENCY: Food and Drug Administration, HHS.
ACTION: Notice.
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SUMMARY: The Food and Drug Administration (FDA) is announcing the
availability of a draft guidance entitled ``Guidance for the
Preparation of a Premarket Notification Application for Processed Human
Dura Mater.'' This draft guidance document discusses issues that should
be addressed in a premarket notification (510(k)) application submitted
to establish the substantial equivalence of a proposed processed human
dura mater device to other similar products in commercial distribution.
This draft guidance document also provides a brief background on
processed human dura mater regulation. It is intended to replace the
guidance document ``Guide for 510(k) Review of Processed Human Dura
Mater'' dated June 26, 1990. This guidance incorporates recommendations
from the October 6, 1997, and April 16, 1998, meetings of the FDA
Transmissible Spongiform Encephalopathies Advisory Committee (FDA TSE
Advisory Committee), which discussed the manufacture and clinical use
of processed human dura mater products.
DATES: Written comments concerning this draft guidance must be
submitted by January 12, 2000.
ADDRESSES: See the SUPPLEMENTARY INFORMATION section for information on
electronic access to the draft guidance. Submit written requests for
single copies on a 3.5'' diskette of the draft guidance document
entitled ``Guidance for the Preparation of a Premarket Notification
Application for Processed Human Dura Mater'' to the Division of Small
Manufacturers Assistance (HFZ-220), Center for Devices and Radiological
Health, Food and Drug Administration, 1350 Piccard Dr., Rockville, MD
20850. Send two self-addressed adhesive labels to assist that office in
processing your request, or fax your request to 301-443-8818.
Submit written comments on the draft guidance to the Dockets
Management Branch, (HFA-305), Food and Drug Administration, 5630
Fishers Lane, rm. 1061, Rockville, MD 20852.
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
Processed human dura mater was in commercial distribution before
the enactment of the 1976 Medical Device Amendments to the Federal
Food, Drug, and Cosmetic Act. While a classification recommendation was
discussed at the February 2, 1990, meeting of the Neurological Devices
Advisory Panel, product classification was not finalized. In March
1997, the World Health Organization (WHO) recommended (based on
concerns of Creutzfeldt Jakob Disease (CJD) transmission that processed
human dura mater no longer be used, especially in neurosurgery, unless
no alternative was available. At the same time, the Japanese Health and
Welfare Ministry banned the use of processed human dura mater in brain
surgery in Japan.
Because FDA established safeguards and guidelines in 1990 to
minimize the possibility of CJD transmission by processed human dura
mater implantation, and because there were no confirmed cases of CJD
transmission related to the use of processed human dura mater in the
United States as of March 1997, FDA did not restrict the distribution
of processed human dura mater in the United States. However, the
decision was made to hold public meetings of the FDA TSE Advisory
Committee to reevaluate the safety of processed human dura mater grafts
with respect to surgical use and CJD transmission.
On October 6, 1997, the FDA TSE Advisory Committee met to consider
information provided by FDA, industry, CDC, National Institutes of
Health (NIH), the neurology medical community, and other
internationally recognized experts concerning the clinical benefits and
risks of CJD transmission associated with processed human dura mater
grafts. At the conclusion of this meeting, the committee recommended
unanimously that neurosurgeons should avoid the use of processed human
dura mater whenever possible. The committee concluded, however, that
the final decision to use processed human dura mater should be left to
the discretion of the treating neurosurgeon, as long as the human dura
mater is procured and processed following certain safety measures.
[[Page 55737]]
To improve the safety of processed human dura mater, and based
upon the committee's recommendations, on March 6, 1998, FDA sent
letters to providers of processed human dura mater requesting that they
implement specific measures that may be beyond their standard operating
procedures. On April 16, 1998, FDA presented to the FDA TSE Advisory
Committee proposed revisions to the committee recommendations from the
October 6, 1997, meeting. These revisions took into consideration the
responses from the processed human dura mater suppliers to the FDA
letter of March 6, 1998. This guidance was prepared to replace the
existing FDA guidance ``Guide for 510(k) Review of Processed Human Dura
Mater'' dated June 26, 1990, and to incorporate the recommendations
received from the FDA TSE Advisory Committee and the responses from
manufacturers.
II. Significance of Guidance
This draft guidance document represents the agency's current
thinking on the preparation of a premarket notification for processed
human dura mater. It does not create or confer any rights for or on any
person and does not operate to bind FDA or the public. An alternative
approach may be used if such approach satisfies the applicable statute,
regulations, or both.
The agency has adopted Good Guidance Practices (GGP's), which set
forth the agency's policies and procedures for the development,
issuance, and use of guidance documents (62 FR 8961, February 27,
1997). This draft guidance document is issued as a Level 1 guidance
consistent with GGP's. Public comment prior to implementation of this
guidance document is not required because the guidance is needed to
address a significant public health issue. However, the agency did
solicit input from the FDA TSE Advisory Committee and processed human
dura mater suppliers provided comments on FDA's approach in response to
FDA's March 6, 1998, letter.
III. Electronic Access
In order to receive the ``Guidance for the Preparation of a
Premarket Notification Application for Processed Human Dura Mater'' via
your fax machine, call the CDRH Facts-On-Demand (FOD) system at 800-
899-0381 or 301-827-0111 from a touch tone telephone. At the first
voice prompt press 1 to access DSMA Facts, at the second voice prompt
press 2, and then enter the document number (054) followed by the pound
sign(#). Then follow the remaining voice prompts to complete your
request.
Persons interested in obtaining a copy of the draft guidance may
also do so using the World Wide Web (WWW). CDRH maintains an entry on
the WWW for easy access to information including text, graphics, and
files that may be downloaded to a personal computer with access to the
web. Updated on a regular basis, the CDRH home page includes ``Guidance
for the Preparation of a Premarket Notification Application for
Processed Human Dura Mater,'' device safety alerts, Federal Register
reprints, information on premarket submissions (including lists of
approved applications and manufacturers' addresses), small
manufacturers' assistance, information on video conferencing and
electronic submissions, Mammography Matters, and other device-oriented
information. The CDRH home page may be accessed at http://www.fda.gov/
cdrh. The ``Guidance for the Preparation of a Premarket Notification
Application for Process Human Dura Mater'' will be available at http://
www.fda.gov/cdrh/ode/054.pdf.
IV. Comments
Interested persons may submit to the Dockets Management Branch
(address above) written comments regarding this draft guidance. Two
copies of any comments are to be submitted, except individuals may
submit one copy. Comments should be identified with the docket number
found in brackets in the heading of this document. A copy of the draft
guidance and received comments are available for public examination in
the Dockets Management Branch between 9 a.m. and 4 p.m., Monday through
Friday.
Dated: September 21, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 99-26720 Filed 10-13-99; 8:45 am]
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