U.S. flag An official website of the United States government

U.S. Food and Drug Administration
  1. Home
  2. Regulatory Information
  3. Search for FDA Guidance Documents
  4. Review Criteria For Premarket Approval of In Vitro Diagnostic Devices for Detection of Antibodies to Parvovirus B19
  1. Search for FDA Guidance Documents

GUIDANCE DOCUMENT

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

Download the Final Guidance Document
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.

Submit Comments

Submit Comments Online

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.

 
Back to Top