This is a flexible document which represents the current major concerns and issues regarding in vitro diagnostic devices as based on recent scientific and clinical experience and on traditional submissions by manufacturers. As advancements are made in science and medicine, these review criteria will be evaluated and revised as necessary to accomodate new knowledge.
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.