03-5792. Medical Devices: Draft Guidance for Industry and FDA Reviewers; Statistical Guidance on Reporting Results From Studies Evaluating Diagnostic Tests; Availability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.

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The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA reviewers entitled “Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests; Draft Guidance for Industry and FDA Reviewers.” This draft guidance is regarding the submission of premarket notification and premarket approval applications (PMAs) for diagnostic tests. The draft guidance describes some statistically appropriate practices for reporting results from different studies evaluating diagnostic tests and identifies some common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 This draft guidance is neither final, nor is it in effect at this time.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Submit written or electronic comments on this draft guidance by June 10, 2003.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Submit written requests for single copies of the draft guidance on a 3.5″ diskette to the Division of Small Manufacturers, International, and Consumer Assistance (HFZ-220), Center for Devices and Radiological Health, Food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 Submit written comments concerning this draft guidance to the Dockets Management Branch (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852.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 See the SUPPLEMENTARY INFORMATION section for information on electronic access to the draft guidance.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 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 (#). 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.