We have developed a draft document entitled "Review Criteria for Assessment of Hepatitis B "e" Antigen and Antibody to Hepatitis B "e" Antigen ". Since the document lists items we will be reviewing, it is intended to assist manufacturing the preparation of premarket approval submissions for these types of devices.
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:
Food and Drug Administration
5630 Fishers Lane, Rm 1061
Rockville, MD 20852
All comments should be identified with the title of the guidance.