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GUIDANCE DOCUMENT

Review Criteria for Devices Assisting in the Diagnosis of C. Difficile Associated Diseases May 1990

Download the Final Guidance Document
Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
Office of Medical Products and Tobacco, Center for Devices and Radiological Health

This is a flexible document which represents the current major concerns and issues regarding in vitro diagnostic devices as based on recent scientific and clinical experience and on traditional submissions by manufacturers. As advancements are made in science and medicine, these review criteria will be evaluated and revised as necessary to accomodate new knowledge.

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Submit Comments Online

You can submit online or written comments on any guidance at any time (see 21 CFR 10.115(g)(5))

If unable to submit comments online, please mail written comments to:

Dockets Management
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852

All written comments should be identified with this document's docket number: FDA-2020-D-0957.