[Federal Register: March 8, 2000 (Volume 65, Number 46)]
[Notices]
[Page 12271-12272]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]
[DOCID:fr08mr00-75]
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DEPARTMENT OF HEALTH AND HUMAN SERVICES
Food and Drug Administration
[Docket No. 00D-0109]
Draft Guidance on Review Criteria for Assessment of Antimicrobial
Susceptibility Devices; 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availability of the draft guidance entitled ``Guidance on Review
Criteria for Assessment of Antimicrobial Susceptibility Devices.'' This
draft guidance is neither final nor is it in effect at this time. This
guidance document would serve as a special control for the
reclassification of fully automated short-term incubation cycle
antimicrobial susceptibility devices from class III to class II.
DATES: Submit written comments concerning this guidance by June 7,
2000.
ADDRESS: 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electronic access to the draft guidance.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single copies on a 3.5" diskette of the draft guidance document
entitled ``Guidance on Review Criteria for Assessment of Antimicrobial
Susceptibility Devices'' to the Division of Small Manufacturers
Assistance (HFZ-220), Center for Devices and Radiological Health
(CDRH), 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 concerning this guidance to the Dockets
Management Branch, (HFA-305), Food and Drug Administration, rm. 1061,
5630 Fishers Lane, Rockville, MD 20852. Comments should be identified
with the docket number found in brackets in the heading of this
document.
[[Page 12272]]
FOR FURTHER INFORMATION CONTACT: Joseph L. Hackett, Center for Devices
and Radiological Health (HFZ-440), Food and Drug Administration, 9200
Corporate Blvd., Rockville, MD 20850, 301-594-3084.
SUPPLEMENTARY INFORMATION:
I. Background
On July 2, 1997, FDA received a petition from bioMerieux Vitek,
Inc., requesting reclassification of the fully automated short-term
incubation cycle antimicrobial susceptibility devices from class III
(premarket approval) to class II (special controls). Based on the
petition, a meeting of the Microbiology Devices Panel (the Panel) was
convened on February 13, 1998, to obtain the Panel's recommendation on
the requested change in classification. The Panel unanimously
recommended that fully automated short-term incubation cycle
antimicrobial susceptibility devices be reclassified from class III to
class II. This guidance document, which takes into consideration the
Panel's recommendations and FDA's review experience, would be the
special control for the reclassified device.
II. Significance of Guidance
This draft guidance document represents the agency's current
thinking on fully automated short-term incubation cycle antimicrobial
susceptibility devices. 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. Designation of this guidance
document as a special control means that manufacturers attempting to
establish that their device is substantially equivalent to a predicate
device must demonstrate that the proposed device complies with either
the specific recommendations of this guidance or some alternative
control that provides equivalent assurances of safety and
effectiveness.
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 document is issued as a Level 1 guidance
consistent with GGP's.
III. Electronic Access
In order to receive a copy of the draft guidance entitled
``Guidance on Review Criteria for Assessment of Antimicrobial
Susceptibility Devices'' via your fax machine, call the CDRH Facts-On-
Demand (FOD) 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 (631)
followed by the pound sign (#). Then 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. 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. Updated on a regular basis, the CDRH
home page includes ``Guidance on Review Criteria for Assessment of
Antimicrobial Susceptibility Devices,'' 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 on Review Criteria for Assessment of Antimicrobial
Susceptibility Devices'' will also be available at http://www.fda.gov/
cdrh.
IV. Comments
Interested persons may, on or before June 7, 2000, submit to Docket
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 are to be identified with the
docket number found in brackets in the heading of this document. The
guidance document and received comments may be seen in the Dockets
Management Branch between 9 a.m. and 4 p.m., Monday through Friday.
Dated: February 9, 2000.
Linda S. Kahan,
Deputy Director for Regulations Policy, Center for Devices and
Radiological Health.
[FR Doc. 00-5524 Filed 3-7-00; 8:45 am]
BILLING CODE 4160-01-F