📄FDA Draft Guidance on 510(k) Clearance Transfer Available
Transfer of a Premarket Notification (510(k)) Clearance-Questions and Answers; Draft Guidance for Industry and Food and Drug Administration Staff; Availability
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The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Transfer of a Premarket Notification (510(k)) Clearance--Questions and Answers."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 This draft guidance is not final nor is it for implementation at this time.
Agencies
- Health and Human Services Department
- Food and Drug Administration
Business Impact
$$ - Med
The draft guidance addresses compliance and regulatory requirements for businesses involved in the manufacture and transfer of medical devices under the 510(k) framework. Business owners need to be aware of the need to register devices and follow transfer protocols. This guidance may impact ongoing operations and strategic decisions related to ownership transfers.