H.R. 6594 — Medical Device Recall Improvement Act of 2025

This section establishes an electronic notification format for medical device recalls (new FFDCA §518B) and patient notification requirements (new FFDCA §518C). Under §518B, the Secretary of Health and Human Services must publish the electronic format within two years of enactment, specifying mandatory data elements such as manufacturer/importer details, recall reason, device identifier, and information on risks and mitigation for user facilities, health professionals, and patients; manufacturers and importers must use this format for notifications to the Secretary starting 180 days after its establishment, with the Secretary conducting an initial review within two business days and specifying shared information within three business days thereafter, after which manufacturers and importers must notify facilities and professionals electronically (with subsequent notifications as needed); and the Secretary must maintain a public, downloadable database of these notifications. Authorizes $6.7 million for FY2026, $1.7 million for FY2027, and $1 million annually for FY2028-FY2030 for implementation. Under §518C, recall strategies must notify patients treated by device user facilities or health professionals with the device; notifications to facilities and professionals must describe patient risks and direct them to inform patients; applies to class I or II recalls of class II or III devices used outside facilities that are implanted, life-sustaining or life-supporting, or used significantly in pediatric populations; and prohibits requiring facilities or professionals to share patient information with manufacturers or importers.

This section adds to the list of prohibited acts under the Federal Food, Drug, and Cosmetic Act (1) the refusal or failure to submit notifications in accordance with paragraphs (1) and (2) of section 518B(b), and (2) the refusal or failure to provide notice in accordance with section 518C.