📋FDA Notice on Proposed Information Collection for 510(k) Reviews
The Food and Drug Administration (FDA or Agency) is announcing an opportunity for public comment on the proposed collection of certain information by the Agency. Under the Paperwork Reduction Act of 1995 (PRA), Federal Agencies are required to publish notice in the Federal Register concerning each proposed collection of information, including each proposed extension of an existing collection of information, and to allow 60 days for public comment in response to the notice. This notice solicits comments on information collection associated with the 510(k) Third-Party Review Program.
Learn More📄FDA Draft Guidance on 510(k) Clearance Transfer Available
The Food and Drug Administration (FDA or Agency) is announcing the availability of the draft guidance entitled "Transfer of a Premarket Notification (510(k)) Clearance--Questions and Answers."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 This draft guidance is not final nor is it for implementation at this time.
Learn More