[Federal Register: November 14, 2000 (Volume 65, Number 220)]
[Notices]
[Page 68152-68153]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr14no00-57]
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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Medical Devices Draft Guidance on Guidance for Prescription Use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availability of the draft guidance entitled ``Guidance for Prescription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 The principles described in this draft guidance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 This draft guidance is neither final nor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DATES: Submit written comments on the draft guidance by February 12,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of the draft guidance entitled ``Guidance for Prescription Use Drugs of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 Submit written comments on the draft
guidance to the Dockets Management Branch (HFA-305), Food and Drug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section for information on electronic access to the draft guidance.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This draft guidance recommends data and labeling that manufacturers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://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=http://www.fda.gov/cdrh. ``Guidance for Prescription Use Drugs of Abuse Assays Premarket
Notifications'' will be available at http://frwebgate.access.gpo.gov/cgi-bin/leaving.cgi?from=leavingFR.html&log=linklog&to=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