Transfer of a Premarket Notification (510(k)) Clearance-Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability

الملخص

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Transfer of a Premarket Notification (510(k)) Clearance--Questions and Answers." The purpose of the draft guidance is to provide information on how to notify FDA of the transfer of a premarket notification clearance from one holder to another, and the procedures FDA and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. This draft guidance is not final nor is it in effect at this time.