This ICR collects information from premarket notification (510(k)) clearance holders and parties claiming to be 510(k) holders who wish to voluntarily report a transfer of 510(k) clearance on FDA’s Unified Registration and Listing System (FURLS), outside of the required listing reporting and the annual listing reporting requirement, or who submit 510(k) transfer documentation when more than one party lists the same 510(k). The information notifies FDA of the transfer of a premarket notification clearance from one holder to another and helps to ensure that the public information in FDA’s databases about the current 510(k) holder for a specific device(s) is accurate and up-to-date.
The latest form for Transfer of a Premarket Notification Clearance expires 2021-05-31 and can be found here.
Supporting Statement A
Voluntary reporting of transfer of 510(k) Clearance on FDA's Unified Registration and Listing System (Outside of Annual Listing Reporting Requirement)
Approved without change
|New collection (Request for a new OMB Control Number)||2018-03-14|
Federal Enterprise Architecture: Health - Consumer Health and Safety