[Federal Register Volume 68, Number 48 (Wednesday, March 12, 2003)]
[Notices]
[Pages 11871-11872]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-5792]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 03D-0044]


Medical Devices: Draft Guidance for Industry and FDA Reviewers; 
Statistical Guidance on Reporting Results From Studies Evaluating 
Diagnostic Tests; 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availability of a draft guidance for industry and FDA reviewers 
entitled ``Statistical Guidance on Reporting Results from Studies 
Evaluating Diagnostic Tests; Draft Guidance for Industry and FDA 
Reviewers.'' This draft guidance is regarding the submission of 
premarket notification and premarket approval applications (PMAs) for 
diagnostic tests. The draft guidance describes some statistically 
appropriate practices for reporting results from different studies 
evaluating diagnostic tests and identifies some common practices that 
may not provide sufficient information to support submission. Special 
attention is given to describing a practice called discrepant 
resolution and its associated problems. This draft guidance is neither 
final, nor is it in effect at this time.

DATES:  Submit written or electronic comments on this draft guidance by 
June 10, 2003. General comments on agency guidance documents are 
welcome at any time.

ADDRESSES: Submit written requests for single copies of the draft 
guidance on a 3.5'' diskette to the Division of Small Manufacturers, 
International, and Consumer 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 Submit written comments concerning this draft guidance to 
the Dockets Management Branch (HFA-305), Food and Drug Administration, 
5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic 
comments to http://www.fda.gov/dockets/ecomments. See the SUPPLEMENTARY 
INFORMATION section for information on electronic access to the draft 
guidance.

FOR FURTHER INFORMATION CONTACT: Kristen L. Meier, Center for Devices 
and Radiological Health (HFZ-542), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 301-594-0616.

SUPPLEMENTARY INFORMATION:

I. Background

    On February 11, 1998, the Center for Devices and Radiological 
Health (CDRH) convened a joint meeting of the Microbiology Devices 
Panel, Hematology and Pathology Devices Panel, Clinical Chemistry and 
Toxicology Devices Panel, and Immunology Devices Panel of the Medical 
Devices Advisory Committee. The purpose of the meeting was to obtain 
recommendations on
    * * * appropriate data collection, analysis, and resolution of 
discrepant results, using sound scientific and statistical analysis 
to support indications for use of the in vitro diagnostic devices * 
* * when the new device is compared to another device, a recognized 
reference method or `gold standard,' or other procedures not 
commonly used, and/or clinical criteria for diagnosis * * *
(63 FR 4458, January 29, 1998). Based on discussions from that meeting, 
this draft guidance describes some statistically appropriate practices 
for reporting results from different studies evaluating diagnostic 
tests and identifies common inappropriate practices. The draft guidance 
also describes a practice called discrepant resolution and its 
associated problems.
    This level 1 draft guidance is being issued consistent with FDA's 
good guidance practices regulation (21 CFR 10.115). The draft guidance 
document represents the agency's current thinking on statistically 
appropriate practices for reporting results from different studies 
evaluating diagnostic tests. 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

[[Page 11872]]

approach may be used if such approach satisfies the applicable statutes 
and regulations.

II. Comments

    Interested persons may submit to the Dockets Management Branch (see 
ADDRESSES) written or electronic comments regarding this document. 
Submit a single copy of electronic comments or two hard copies of any 
mailed comments, except that individuals may submit one hard copy. 
Comments are to be identified with the docket number found in brackets 
in the heading of this document. The draft guidance and received 
comments may be seen in the Dockets Management Branch between 9 a.m. 
and 4 p.m., Monday through Friday.

III. Electronic Access

    To receive ``Statistical Guidance on Reporting Results from Studies 
Evaluating Diagnostic Tests'' via your fax machine, call the CDRH 
Facts-On-Demand system at 800-899-0381 or 301-827-0111 from a touch-
tone telephone. Press 1 to enter the system. At the second voice prompt 
press 1 to order a document. Enter the document number (1428) followed 
by the pound sign ([numsign]). Follow the remaining voice prompts to 
complete your request.
    Persons interested in obtaining a copy of the draft guidance may 
also do so by using the Internet. CDRH maintains an entry on the 
Internet for easy access to information including text, graphics, and 
files that may be downloaded to a personal computer with Internet 
access. Updated on a regular basis, the CDRH home page includes 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 Web site may be 
accessed at http://www.fda.gov/cdrh. A search capability for all CDRH 
guidance documents is available at http://www.fda.gov/cdrh/guidance.html. Guidance documents are also available on the Dockets 
Management Branch Web site at http://www.fda.gov/ohrms/dockets.

    Dated: March 4, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-5792 Filed 3-11-03; 8:45 am]
BILLING CODE 4160-01-S