[Federal Register Volume 65, Number 220 (Tuesday, November 14, 2000)]
[Notices]
[Pages 68152-68153]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-29110]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-1587]


Medical Devices Draft Guidance on Guidance for Prescription Use 
Drugs of Abuse Assays Premarket Notifications; 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availability of the draft guidance entitled ``Guidance for Prescription 
Use Drugs of Abuse Assays Premarket Notifications.'' FDA is issuing 
this guidance to express the general principles FDA applies in 
evaluating premarket notifications (510(k)s) for prescription use drugs 
of abuse assays. The principles described in this draft guidance 
document apply only to in vitro diagnostic (IVD) submissions for 510(k) 
clearance for these devices. This draft guidance is neither final nor 
in effect at this time.

DATES: Submit written comments on the draft guidance by February 12, 
2001.

ADDRESSES: Submit written requests for single copies on a 3.5" diskette 
of the draft guidance entitled ``Guidance for Prescription Use Drugs of 
Abuse Assays Premarket Notifications'' 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

[[Page 68153]]

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 Submit written comments on the draft 
guidance to the Dockets Management Branch (HFA-305), Food and Drug 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. 
Comments should be identified with the docket number found in brackets 
in the heading of this document. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the draft guidance.

FOR FURTHER INFORMATION CONTACT: Jean M. Cooper, Center for Devices and 
Radiological Health (HFZ-440), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-1243.

SUPPLEMENTARY INFORMATION:

I. Background

    This draft guidance recommends data and labeling that manufacturers 
should submit in support of substantial equivalence for prescription 
use drugs of abuse assays. The recommendations and general principles 
in this draft guidance are provided to assist manufacturers in the 
preparation of premarket notifications (510(k)s) for these devices. 
This document will supersede the document, ``Review Criteria for 
Assessment of In Vitro Diagnostic Devices for Drugs of Abuse Assays 
Using Various Methodologies,'' August 31, 1995. This draft guidance 
explains the types of studies to conduct and how to present the study 
data in greater detail than the document it is replacing.

II. Significance of Guidance

    This draft guidance represents the agency's current thinking 
regarding data and labeling for prescription use drugs of abuse device 
submissions for 510(k) clearance. 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) and 
published the final rule, which set forth the agency's regulations for 
the development, issuance, and use of guidance documents (65 FR 56468, 
September 19, 2000). This guidance document is issued as a Level 1 
draft guidance consistent with the GGP's.

III. Electronic Access

    In order to receive the draft guidance entitled ``Guidance for 
Prescription Use Drugs of Abuse Assays Premarket Notifications'' 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 (152) followed by the pound sign (#). Follow the 
remaining voice prompts to complete your request.
    Persons interested in obtaining a copy of the guidance may also do 
so using the Internet. The Center for Devices and Radiological Health 
(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 access to the Internet. Updated on a 
regular basis, the CDRH home page includes the civil money penalty 
guidance documents package, 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. ``Guidance for Prescription Use Drugs of Abuse Assays Premarket 
Notifications'' will be available at http://www.fda.gov/cdrh/ode/guidance/152.pdf.

IV. Comments

    Interested persons may submit to Dockets Management Branch (address 
above) written comments regarding this draft guidance by February 12, 
2001. Two copies of any comments are to be submitted, except 
individuals may submit one 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.

    Dated: November 2, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and 
Radiological Health.
[FR Doc. 00-29110 Filed 11-8-00; 4:21 pm]
BILLING CODE 4160-01-F