Medical Device Recall Improvement Act

This bill amends the Federal Food, Drug, and Cosmetic Act to improve medical device recall notifications by establishing an electronic format and requiring patient notification. It adds two new sections (518B and 518C) to the Act and creates new prohibited acts for noncompliance.

Sec. 2, Electronic notification format for device recalls: Within two years of enactment, the Secretary of Health and Human Services must publish an electronic form and manner for recall notifications. The form must include mandatory data elements such as the manufacturer or importer name and contact information, the reason for the recall, the specific device, its unique device identifier, and information for device user facilities, health professionals, and patients (including risks and actions to reduce risk). Optional data elements may be included. Manufacturers and importers must submit required notifications through this electronic format starting 180 days after the form is established. The Secretary must conduct an initial review within two business days of receiving a notification and inform the manufacturer or importer within three business days of what information should be shared with device user facilities and health professionals. Manufacturers and importers must then submit notifications to device user facilities and health professionals through the electronic format after the initial review, and provide additional notifications as necessary. The Secretary must maintain a publicly accessible, downloadable electronic database of device notifications. The bill authorizes appropriations of $6,700,000 for fiscal year 2024, $1,700,000 for fiscal year 2025, and $1,000,000 for each of fiscal years 2026 through 2028, to remain available until expended.

Sec. 2, Patient notification: The Secretary must require that any recall strategy provides for notice to patients treated with the device by device user facilities and health professionals. Recall notifications from the manufacturer or importer must include information about risks to those patients and instruct device user facilities and health professionals to share that information with patients. This applies to any class I or class II recall for a class II or class III device that is used outside of device user facilities and is implanted, life-sustaining, life-supporting, or used significantly in pediatric populations. Nothing in this section requires device user facilities or health professionals to provide patient information to the manufacturer or importer.

Sec. 3, Prohibited acts: The bill adds two new prohibited acts to the Federal Food, Drug, and Cosmetic Act: the refusal or failure to submit notifications in accordance with the electronic notification requirements, and the refusal or failure to provide patient notice as required.