[Federal Register Volume 64, Number 173 (Wednesday, September 8, 1999)]
[Notices]
[Pages 48843-48844]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-23229]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration
[Docket No. 99D-2726]


Medical Devices; Draft Guidance on Labeling for Laboratory Tests; 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availability of the draft guidance entitled `` Draft Guidance on 
Labeling for Laboratory Tests.'' This draft guidance is not final nor 
is it in effect at this time. The draft guidance is intended to 
identify the information that should be provided to FDA for labeling 
the diagnostic performance of laboratory tests. FDA intends to 
recognize two major categories of endpoints for assessing diagnostic 
performance of new ``in vitro diagnostic'' assays.

DATES: Written comments concerning this draft guidance must be received 
by December 7, 1999.

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electronic access to the draft guidance.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single copies on a 3.5'' diskette of the draft guidance entitled 
``Draft Guidance on Labeling for Laboratory Tests'' to the Division of 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    Submit written comments on the draft guidance to the Dockets 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, 2098 
Gaither Rd., Rockville, MD 20850, 301-594-3084.

SUPPLEMENTARY INFORMATION:

I. Background

    The labeling and evaluation of laboratory test performance should 
compare a new product's test results to some appropriate and relevant 
diagnostic benchmark that can be used to correlate results from a new 
test with the clinical status or condition of individuals or patients 
for whom the test is intended to be used. Determination of the clinical 
status of patients whose specimens are used in an evaluation may be 
based on laboratory and/or clinical endpoints. FDA recognizes two major 
categories of endpoints for assessing performance of new laboratory 
assays: (1) ``True'' diagnostic state (patient clinical status or 
condition) or operational ``truth,'' and (2) laboratory equivalence 
where the test is characterized in terms of a

[[Page 48844]]

comparison to a legally marketed predicate.
    This draft guidance represents the agency's current thinking on 
labeling of diagnostic performance for new laboratory 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 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.

II. Electronic Access

    In order to receive the ``Draft Guidance on Labeling for Laboratory 
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. At the first 
voice prompt press 1 to access DSMA Facts, at second voice prompt press 
2, and then enter the document number (1352) followed by the pound sign 
(#). Then follow the remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the draft 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 
WWW. Updated on a regular basis, the CDRH home page includes the 
``Draft Guidance on Labeling for Laboratory Tests,'' 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''.

III. Comments

    Interested persons may submit to the Dockets Management Branch 
(address above) written comments regarding this draft guidance. Two 
copies of any comments are to be submitted, except that 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: August 24, 1999.
 Linda S. Kahan,
 Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 99-23229 Filed 9-7-99; 8:45 am]
BILLING CODE 4160-01-F