DRAFT Guidance for Industry and FDA Staff
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This draft guidance provides information on how to notify FDA of the transfer of a 510(k) clearance from one person to another, and the procedures FDA and industry should use to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.
FDA also added a requirement that the FDA-assigned premarket submission number of cleared 510(k) devices be included with device listing information. When an owner or operator creates a listing for a 510(k) device as a manufacturer, specification developer, repacker/relabeler, single-use device reprocessor, or remanufacturer, this signals to FDA that they are the current 510(k) holder for that device, because these entities are responsible for the commercial distribution of the device. Listing information is required to be updated at least annually and there may only be one 510(k) holder for a device at a time; therefore, this provides FDA with current 510(k) holder information by 510(k) number.
Download FDA Draft Guidance
Implementation of Device Registration and Listing Requirements Enacted in the Public Health Security and Bioterrorism Preparedness and Response Act of 2002, the Medical Device User Fee and Modernization Act of 2002, and Title II of the Food and Drug Administration Amendments Act of 2007
August 2, 2012
The Food and Drug Administration (FDA) is amending its regulations to reflect recent statutory amendments to the device registration and listing provisions of the Federal Food, Drug, and Cosmetic Act (FD&C Act). The Food and Drug Administration Amendments Act of 2007 (FDAAA), enacted on September 27, 2007, amended the FD&C Act by requiring domestic and foreign device establishments to begin submitting their registration and device listing information to FDA by electronic means rather than on paper forms, and also specified the timeframes when establishments are required to submit such information. In addition, this final rule would facilitate FDA’s collection of additional registration information from foreign establishments as required by the Public Health Security and Bioterrorism Preparedness and Response Act of 2002 (Bioterrorism Act). The final rule will update certain provisions in the regulations to improve the quality of registration and listing information available to FDA. FDA relies on having complete and accurate registration and listing information in order to accomplish a number of important public health objectives.
DATES: This final rule is effective October 1, 2012.
Download Federal Register Notice: Final Rule in PDF
Last Updated: 2016-01-24