Transfer of a Premarket Notification Clearance

OMB 0910-0852

OMB 0910-0852

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.

OMB Details

Voluntary reporting of transfer of 510(k) Clearance on FDA's Unified Registration and Listing System (Outside of Annual Listing Reporting Requirement)

Federal Enterprise Architecture: Health - Consumer Health and Safety


© 2021 OMB.report | Privacy Policy