To improve medical device recall notifications by amending the Federal Food, Drug, and Cosmetic Act to establish an electronic format for device recall notifications, and for other purposes.
This bill establishes a standardized electronic system for notifying the public about medical device recalls. The Food and Drug Administration must create an electronic format and form for device manufacturers and importers to use when reporting recalls, which must include specific details like the manufacturer's contact information, the reason for the recall, unique device identifiers, and information about health risks for both medical professionals and patients. Within 180 days of the FDA establishing this format, manufacturers must use it to submit all recall notifications to the FDA, which has 2 to 3 business days to review and respond with information that should be shared with healthcare facilities and professionals. The bill also requires that patients who received implanted, life-sustaining, or life-supporting devices be notified about recalls through their healthcare providers, and makes it a violation of federal law for manufacturers to refuse or fail to comply with these notification requirements. The legislation authorizes $6.7 million in funding for fiscal year 2024 to implement these requirements, decreasing to $1 million annually through 2028.
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