Announcing Draft Guidance on the Transfer of a Premarket Notification (510(k)) Clearance

Today the FDA published draft guidance on the Transfer of a Premarket Notification (510(k)) Clearance. When finalized, this guidance will provide information on:

• how to notify the FDA of the transfer of a 510(k) clearance from one holder to another
• the procedures the FDA and Industry should use to ensure accurate and up-to-date information in the FDA’s databases

The ability to identify the current holder of each 510(k) clearance will ensure that the FDA can locate and contact the correct individual(s) when necessary.

We welcome your comments and suggestions regarding this draft guidance. The comment period will be open for 90 days.

Thank you,

Food and Drug Administration

Center for Devices and Radiological Health