- Docket Number:
- Issued by:
Guidance Issuing OfficeOffice 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.
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.