6 January 2004
Source: http://www.access.gpo.gov/su_docs/aces/fr-cont.html

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[Federal Register: January 5, 2004 (Volume 69, Number 2)]
[Notices]
[Page 371-372]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr05ja04-70]

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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 1990D-0194]


Radioimmunoassay Analysis of Hair to Detect the Presence of Drugs
of Abuse; Revocation of Compliance Policy Guide 7124.06

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice.

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SUMMARY: The Food and Drug Administration (FDA) is announcing the
revocation of the compliance policy guide (CPG) entitled ``Sec. 370.200
RIA Analysis of Hair to Detect the Presence of Drugs of Abuse (CPG
7124.06).'' This CPG no longer reflects current agency policy.

DATES: The revocation is effective January 5, 2004.

ADDRESSES: Submit written requests for single copies of CPG 7124.06 to
the Division of Compliance Policy (HFC-230), Food and Drug
Administration, 5600 Fishers Lane, Rockville, MD 20857, FAX 301-827-
0482.
    A copy of the CPG may be seen in the Division of Dockets Management
(HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061,
Rockville, MD, between 9 a.m. and 4 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Jeffrey B. Governale, Division of
Compliance Policy (HFC-230), Food and Drug Administration, 5600 Fishers
Lane, Rockville, MD 20857, 301-827-0411.

SUPPLEMENTARY INFORMATION:

I. Background

    FDA issued the CPG entitled ``Sec. 370.200 RIA Analysis of Hair to
Detect the Presence of Drugs of Abuse (CPG 7124.06)'' on May 31, 1990.
The CPG stated that the use of radioimmunoassay (RIA) to analyze hair
for the presence of drugs of abuse lacked scientific evidence of its
safety and effectiveness, as defined in 21 CFR 860.7. Accordingly, the
CPG indicated that approved premarket approval applications (PMAs) were
necessary before commercially distributing these types of devices.
    Since publication of this CPG, more than 88 scientific articles on
drugs of abuse testing in hair have been published in the peer-reviewed
scientific literature. There has been extensive discussion about the
analytical performance, the clinical parameters, and sources of error
and testing differences for this technology compared to other
technologies. FDA has reviewed a number of hair tests and found these
to be substantially equivalent to predicate devices measuring drugs of
abuse in other matrices. Given these scientific developments and
product clearances,

[[Page 372]]

FDA is revoking CPG 7124.06, in its entirety, to eliminate obsolete
compliance policy.
    Any person who proposes to introduce into commercial distribution
an in vitro diagnostic device that is intended to test human hair for
drugs of abuse is required to submit a premarket notification (510(k))
to FDA. However, in accordance with Sec.  864.3260 (21 CFR 864.3260),
over-the-counter test sample collection systems for drugs of abuse
testing (systems sold for use in nonmedical settings such as insurance,
workplace, and home) are exempt from the 510(k) submission requirement
as long as the laboratory test (whether for urine, hair, or other
matrices) has been cleared or approved by FDA, the laboratory is
recognized as capable of performing the testing, and the system is
properly labeled. (See 21 CFR 809.40 and Sec.  864.3260.)

    Dated: December 23, 2003.
John M. Taylor,
Associate Commissioner for Regulatory Affairs.
[FR Doc. 04-16 Filed 1-2-04; 8:45 am]

BILLING CODE 4160-01-S