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GUIDANCE DOCUMENT

Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19 May 1992

Final
Docket Number:
FDA-2020-D-0957
Issued by:
Guidance Issuing Office
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 antibodies to B19 in serum or plasma specimens may be approved for marketing. This document is an adjunct to the CFR and the FDA 87-4214 Premarket Approval (PMA) Manuel.


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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
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5630 Fishers Lane, Rm 1061
Rockville, MD 20852

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

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