[Federal Register Volume 65, Number 46 (Wednesday, March 8, 2000)]
[Notices]
[Pages 12271-12272]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 00-5524]


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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Draft Guidance on Review Criteria for Assessment of Antimicrobial 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availability of the draft guidance entitled ``Guidance on Review 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draft guidance is neither final nor is it in effect at this time.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electronic access to the draft guidance.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single copies on a 3.5" diskette of the draft guidance document 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]
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