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GUIDANCE DOCUMENT

Points to Consider for Cervical Cytology Devices July 1994

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 points-to-consider document supplements existing FDA guidance for premarket submission of in vitro diagnostic devices for approval or clearance. The information requested is intended to be comprehensive but may not be all inclusive. The emphasis is on FDA's particular concerns in the review of cytology devices for gynecologic specimens.


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

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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.