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