[Federal Register Volume 68, Number 24 (Wednesday, February 5, 2003)]
[Notices]
[Pages 5890-5891]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 03-2657]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration

[Docket No. 00D-0109]


Medical Devices: Class II Special Controls Guidance Document: 
Antimicrobial Susceptibility Test Systems; Guidance for Industry and 
FDA; 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 guidance entitled ``Class II Special Controls 
Guidance Document: Antimicrobial Susceptibility Test (AST) Systems; 
Guidance for Industry and FDA.'' This guidance document was developed 
as a special control guidance to support the reclassification of the 
fully automated short-term incubation cycle antimicrobial 
susceptibility device from class III to class II. Elsewhere in this 
issue of the Federal Register, FDA is publishing a final rule 
reclassifying the fully automated short-term incubation cycle 
antimicrobial susceptibility device from class III to class II.

DATES: Submit written or electronic comments on agency guidances at any 
time.

ADDRESSES: Submit written requests for single copies on a 3.5'' 
diskette of the guidance entitled ``Class II Special Controls Guidance 
Document: Antimicrobial Susceptibility Test (AST) Systems; Guidance for 
Industry and FDA'' to the Division of Small Manufacturers, 
International, and Consumer 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, 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. Submit electronic comments to http://www.fda.gov//dockets/ecomments. See the SUPPLEMENTARY INFORMATION 
section for information on electronic access to the guidance.

FOR FURTHER INFORMATION CONTACT:  Freddie M. Poole, Center for Devices 
and Radiological Health (HFZ-440), Food and Drug Administration, 9200 
Corporate Blvd., Rockville, MD 20850, 301-594-2096.

SUPPLEMENTARY INFORMATION:

I. Background

    This guidance document was developed as a special control guidance 
to support the reclassification of the fully automated short-term 
incubation cycle antimicrobial susceptibility device from class III to 
class II. Elsewhere in this issue of the Federal Register, FDA is 
publishing a final rule to reclassify

[[Page 5891]]

this type of device from class III to class II. This guidance serves to 
update the information provided in the draft guidance entitled 
``Guidance on Review Criteria for Assessment of Antimicrobial 
Susceptibility Devices'' (65 FR 12271, March 8, 2000). FDA considered 
the comments it received and made changes to the guidance as a result, 
including the revised document title to identify this guidance as a 
special control. FDA believes that special controls, when combined with 
the general controls, will be sufficient to provide reasonable 
assurance of the safety and effectiveness of the fully automated short-
term incubation cycle antimicrobial susceptibility device. After the 
device is reclassified, a manufacturer who intends to market a device 
of this generic type must: (1) Comply with the general controls of the 
Federal Food, Drug, and Cosmetic Act, including the 510(k) requirements 
described in 21 CFR 807.81, (2) address the specific risks to health 
associated with the antimicrobial susceptibility test system, and (3) 
receive a substantial equivalence determination from FDA prior to 
marketing the device.
    This guidance document identifies the classification, product code, 
and classification definition for fully automated short-term incubation 
cycle antimicrobial susceptibility devices. In addition, it identifies 
the risks to health and serves as a special control that, when followed 
and combined with the general controls of the act, will be sufficient 
to address the risks associated with this generic device type and lead 
to a timely review and clearance of a premarket notification under 
section 510(k) of the act (21 U.S.C. 360(k)).

II. Significance of Guidance

    This guidance is being issued consistent with FDA's good guidance 
practices regulation (21 CFR 10.115). This guidance represents the 
agency's current thinking on AST systems. 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 statutes and regulations. Following the effective date 
of the final classification rule (published elsewhere in this issue of 
the Federal Register), any firm submitting a 510(k) premarket 
notification for a fully automated short-term incubation cycle 
antimicrobial susceptibility device will need to address the issues 
covered in the special control guidance. However, the firm need only 
show that its device meets the recommendations of the guidance or in 
some other way provides equivalent assurances of safety and 
effectiveness.

III. Electronic Access

    In order to receive ``Class II Special Controls Guidance Document: 
Antimicrobial Susceptibility Test (AST) Systems; Guidance for Industry 
and FDA,'' you may either send a fax request to 301-443-8818 to receive 
a hard copy of the document, or send an e-mail to [email protected] to 
request a hard copy or electronic copy. Please use the document number 
(631) to identify the guidance you are requesting.
    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 with Internet access. 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 documents are also available on the Dockets Management 
Branch Internet site at http://www.fda.gov/ohrms/dockets.

IV. Comments

    Interested persons may submit to Dockets Management Branch (see 
ADDRESSESS) written or comments regarding this guidance. Two copies of 
any mailed 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. Electronic comments 
may be submitted at http://www.fda.gov/opacom/backgrounders/voice.html. 
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: January 9, 2003.
Linda S. Kahan,
Deputy Director, Center for Devices and Radiological Health.
[FR Doc. 03-2657 Filed 2-4-03; 8:45 am]
BILLING CODE 4160-01-S