FDA Seeks Comment on Proposed Information Collection for UDI Requirements

The FDA seeks input from the public on paperwork requirements related to the unique device identification system (UDI).

The agency is requesting comments on whether the proposed collection of information is necessary for the proper performance of FDA’s functions.

The agency also seeks comments on the accuracy of the FDA’s estimate of burden for the medical device manufacturers in collecting UDI system information.

The FDA estimates the annual burden will total 7,271 hours for reporting, 301,978 hours for recordkeeping and 270,223 hours for third-party disclosures. — Cynthia Jessup