Review Criteria for In Vitro Diagnostic Devices for Detection of IGM Antibodies to Viral Agents
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.
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.