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GUIDANCE DOCUMENT

Review Criteria for In Vitro Diagnostic Devices for Detection of IGM Antibodies to Viral Agents August 1992

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

The purpose of this document is to provide guidance on information to present to the Food and Drug Administration (FDA) before a device to detect IgM antibodies to specific viral agents in serum or plasma specimens may be approved/cleared for marketing. This document is an adjunct to the CFR and the FDA 87-4214 Premarket Approval (PMA) Manual.


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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.