[Federal Register Volume 72, Number 48 (Tuesday, March 13, 2007)]
[Notices]
[Page 11372]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E7-4453]



[[Page 11372]]

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

DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 2003D-0044]


Guidance for Industry and Food and Drug Administration Staff; 
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 the guidance entitled ``Statistical Guidance on 
Reporting Results from Studies Evaluating Diagnostic Tests.'' This 
guidance describes some statistically appropriate practices for 
reporting results from different studies evaluating diagnostic tests 
and identifies some common inappropriate practices. Special attention 
is given to describing a practice called discrepant resolution and its 
associated problems.

DATES: Submit written or electronic comments on this guidance at any 
time. General comments on agency guidance documents are welcome at any 
time.

ADDRESSES: Submit written requests for single copies of the guidance 
document entitled ``Statistical Guidance on Reporting Results from 
Studies Evaluating Diagnostic Tests'' 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 one self-addressed adhesive 
label to assist that office in processing your request, or fax your 
request to 240-276-3151. See the SUPPLEMENTARY INFORMATION section for 
information on electronic access to the guidance.
    Submit written comments concerning this guidance to the Division of 
Dockets Management (HFA-305), Food and Drug Administration, 5630 
Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments 
to http://www.fda.gov/dockets/ecomments. Identify comments with the 
docket number found in brackets in the heading of this document.

FOR FURTHER INFORMATION CONTACT: Kristen Meier, Center for Devices and 
Radiological Health (HFZ-550), Food and Drug Administration, 1350 
Piccard Dr., Rockville, MD 20850, 240-276-3060.

SUPPLEMENTARY INFORMATION:

I. Background

    On February 11, 1998, the Center for Devices and Radiological 
Health (CDRH) convened a joint meeting of the Microbiology, Hematology/
Pathology, Clinical Chemistry/Toxicology and Immunology Devices Panels. 
The purpose of this 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.'' Using the input from that meeting, a draft 
guidance document was developed discussing some statistically valid 
approaches to reporting results from evaluation studies for new 
diagnostic devices. The draft guidance was released for public comment 
on March 12, 2003.
    Following publication of the draft guidance, 11 comments were 
submitted to FDA. Overall, comments were favorable and requested that 
additional information be included in the final guidance. We reviewed 
the comments and took their suggestions into consideration in writing 
this guidance, including consideration of the comments requesting 
greater attention to the use of standard terminology.

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). The guidance represents the 
agency's current thinking on reporting results from 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 requirements of the 
applicable statute and regulations.

III. Electronic Access

    Persons interested in obtaining a copy of the guidance may do so by 
using the Internet. To receive ``Statistical Guidance on Reporting 
Results from Studies Evaluating Diagnostic Tests,'' you may either send 
an e-mail request to [email protected] to receive an electronic copy 
of the document or send a fax request to 240-276-3151 to receive a hard 
copy. Please use the document number 1620 to identify the guidance you 
are requesting.
    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 
manufacturer's 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 Division of Dockets Management Internet site at http://www.fda.gov/ohrms/dockets.

IV. Paperwork Reduction Act of 1995

    This guidance refers to previously approved collections of 
information found in FDA regulations. These collections of information 
are subject to review by the Office of Management and Budget (OMB) 
under the Paperwork Reduction Act of 1995 (44 U.S.C. 3501-3520). The 
collections of information in 21 CFR part 807 have been approved under 
OMB Control No. 0910-0120; and the collections of information in 21 CFR 
part 814 have been approved under OMB Control No. 0910-0231.

V. Comments

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

    Dated: March 2, 2007.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. E7-4453 Filed 3-12-07; 8:45 am]
BILLING CODE 4160-01-S