This bill requires the FDA to establish a standardized electronic system for medical device recall notifications within two years of enactment. Manufacturers and importers must submit recalls through this electronic format, which will include mandatory information such as the device name, manufacturer contact details, reason for recall, unique device identifiers, and specific guidance for healthcare providers and patients about risks and safety actions. The FDA must review notifications within two to three business days and maintain a publicly accessible database of all recall information. Additionally, the bill requires manufacturers to notify patients treated with certain high-risk recalled devices—including implanted devices, life-sustaining or life-supporting devices, and those used in pediatric populations—through healthcare providers and facilities. The legislation authorizes $6.7 million in funding for fiscal year 2026, declining to $1 million annually through 2030, and makes it a violation of federal law for manufacturers to fail to comply with the new notification requirements.
Take Action
Your position
Add a comment
to comment on this bill.
Annotate the text
Highlight any passage on the Summary or Full Text tab to attach a note. Annotations appear on the Annotations tab.