[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]


-----------------------------------------------------------------------

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Medical Devices; Draft Guidance for the Preparation of a 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.

-----------------------------------------------------------------------

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availability of a draft guidance entitled ``Guidance for the 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 This draft guidance document discusses issues that should 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This draft guidance document also provides a brief background on 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DATES: Written comments concerning this draft guidance must be 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electronic access to the draft guidance.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single copies on a 3.5'' diskette of the draft guidance document 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     Submit written comments on the draft guidance to the Dockets 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]
BILLING CODE 4160-01-F