[Federal Register: February 5, 2003 (Volume 68, Number 24)]

[Notices]               

[Page 5890-5891]

From the Federal Register Online via GPO Access [wais.access.gpo.gov]

[DOCID:fr05fe03-65]                         





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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 GWA@CDRH.FDA.GOV 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