FOOD AND DRUG ADMINISTRATION ISSUES NOTICE: TRANSFER OF A PREMARKET NOTIFICATION (510(K)) CLEARANCE-QUESTIONS AND ANSWERS; DRAFT GUIDANCE FOR INDUSTRY AND FOOD AND DRUG ADMINISTRATION STAFF; AVAILABILITY

WASHINGTON, June 5 -- Food and Drug Administration has issued a notice called: Transfer of a Premarket Notification (510(k)) Clearance-Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability.

The notice was published in the Federal Register on June 5 by Grace R. Graham, Deputy Commissioner for Policy, Legislation, and International Affairs.

Summary: The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Transfer of a Premarket Notification (510(k)) Clearance-Questions and Answers." This guidance provides information on the most frequently asked questions regarding transfer of ownership from one 510(k) holder to another. This draft guid...