Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19 May 1992
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Guidance Issuing OfficeCenter 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.
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:
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.