[Federal Register Volume 64, Number 195 (Friday, October 8, 1999)]
[Notices]
[Pages 54902-54903]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-26303]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-3028]


Medical Devices: Draft Guidance on Premarket Approval 
Applications for Assays Pertaining to Hepatitis C Viruses (HCV) That 
Are Indicated for Diagnosis or Monitoring of HCV Infection or 
Associated Disease; 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availability of a draft guidance entitled ``Guidance on Premarket 
Approval Applications for Assays Pertaining to Hepatitis C Viruses 
(HCV) That Are Indicated for Diagnosis or Monitoring of HCV Infection 
or Associated Disease.'' This draft guidance is intended to provide 
current insights on the design, data collection, and data analysis of 
studies that are important to the premarket approval application (PMA) 
approval process for in vitro diagnostic (IVD) devices pertaining to 
HCV. This draft guidance document represents the agency's current 
thinking regarding PMA's for IVD devices that pertain to HCV infection. 
This draft guidance is neither final nor is it in effect at this time.

DATES: Written comments concerning this draft guidance must be 
submitted by January 6, 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electronic access to the draft guidance.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single copies on a 3.5'' diskette of the draft guidance entitled 
``Guidance on Premarket Approval Applications for Assays Pertaining to 
Hepatitis C Viruses (HCV) That Are Indicated for Diagnosis or 
Monitoring of HCV Infection or Associated Disease'' 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     Submit written comments on the draft guidance to the Dockets 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: Joseph L. Hackett, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-3084.

SUPPLEMENTARY INFORMATION:

 I. Background

     This draft guidance is intended to provide recommendations for 
studies to demonstrate performance of assays for detecting evidence of 
infection with HCV. A meeting of the Microbiology Devices Advisory 
Panel was held on February 12, 1998, to obtain suggestions and 
recommendations from the panel regarding scientific information 
necessary for premarket approval of tests for hepatitis viruses. 
Following the panel meeting and subsequent discussions between FDA and 
representatives of the Health Industry Manufacturers Association 
(HIMA), HIMA developed a draft guidance document for tests to detect 
HCV and submitted it to FDA. This draft guidance document issued by FDA 
reflects modifications to HIMA's proposed document and, therefore, does 
not necessarily reflect HIMA's original or current position.

II. Significance of Guidance

     This draft guidance represents the agency's current thinking 
regarding the content of PMA's for IVD devices pertaining to HCV. 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 is issued as a Level 1 guidance consistent 
with GGP's.

III. Electronic Access

     In order to receive the draft guidance entitled ``Guidance on 
Premarket Approval Applications for Assays Pertaining to Hepatitis C 
Viruses (HCV) That Are Indicated for Diagnosis or Monitoring of HCV 
Infection or Associated Disease'' 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 (1353) followed by the pound sign (#). Then follow the remaining 
voice prompts to complete your request.

[[Page 54903]]

     Persons interested in obtaining a copy of the 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 the draft 
guidance entitled ``Guidance on Premarket Approval Applications for 
Assays Pertaining to Hepatitis C Viruses (HCV) That Are Indicated for 
Diagnosis or Monitoring of HCV Infection or Associated Disease,'' 
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 on Premarket 
Approval Applications for Assays Pertaining to Hepatitis C Viruses 
(HCV) That Are Indicated for Diagnosis on Monitoring of HCV Infection 
on Associated Diseases'' will be available at http://www.fda.gov/cdrh.

 IV. Comments

     Interested persons may, on or before January 6, 2000, 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 13, 1999.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-26303 Filed 10-7-99; 8:45 am]
BILLING CODE 4160-01-F