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GUIDANCE DOCUMENT

Review Criteria for Blood Culture Systems August 1991

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

We have developed a draft document entitled, "Review criteria for Assessment of In Vitro Blood Culturing System Diagnostic Devices." Since the document lists items we will be reviewing, it is intended to assist manufacturers in the preparation of marketing submissions for these types of devices.


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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.