Transfer of a Premarket Notification (510(k)) Clearance – Questions and Answers
This draft guidance provides information on how to notify FDA of the transfer of a 510(k) clearance from one person to another, and the procedures FDA and industry should use to ensure public information in FDA’s databases about the current 510(k) holder for a specific device(s) is accurate and up-to-date.
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.