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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

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

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 on this guidance document electronically via docket ID: FDA-2013-S-0610 - Specific Electronic Submissions Intended For FDA's Dockets Management Staff (i.e., Citizen Petitions, Draft Proposed Guidance Documents, Variances, and other administrative record submissions)

If unable to submit comments online, please mail written comments to:

Division of Dockets Management (HFA- 305)
Food and Drug Administration
5630 Fishers Lane, Rm. 1061
Rockville, MD 20852

All comments should be identified with the title of the guidance.