This guidance outlines FDA’s regulatory approach for approval of Class III in vitro diagnostic devices, as well as certain licensed or certain cleared in vitro diagnostic devices in cases, when a previously approved, licensed, or cleared assay is migrating (i.e., transitioning) to another system for which assay performance has not been evaluated by FDA. In this guidance the term “new system” refers to the system (assay, instrument, and software) to which the assay is migrating from a previously approved/licensed/cleared system. The term “old system” refers to the system (assay, instrument and software) which was approved/licensed/cleared from which the assay is migrating to a currently unapproved/unlicensed/uncleared system.
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.