This bill requires the FDA to establish a standardized electronic system for medical device manufacturers and importers to report product recalls within two years of the law's enactment. The electronic format must include specific information such as the manufacturer's contact details, the reason for recall, device identifiers, and guidance for healthcare professionals and patients about the risks and recommended actions. Manufacturers must submit recall notifications to the FDA under this new system starting 180 days after it's established, with the FDA required to review submissions within 2-3 business days and maintain a publicly accessible database of all recalls. Additionally, the bill requires manufacturers to notify patients treated with certain high-risk devices (such as implanted or life-sustaining devices used in children) about recalls through their healthcare providers. The legislation authorizes approximately $6.7 million in funding for fiscal year 2026, declining to $1 million annually through 2030, and makes it a violation of federal law to fail to comply with the new notification requirements.
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