This bill, titled the Medical Device Recall Improvement Act of 2025, mandates the creation of an electronic format for medical device recall notifications. Within two years, the Secretary of Health and Human Services must establish this format, requiring manufacturers and importers to submit comprehensive details such as the reason for recall, specific device identifiers, and information tailored for both healthcare professionals and patients. A key provision requires the Secretary to maintain a publicly accessible, downloadable electronic database of all device recall notifications. Manufacturers must submit these notifications electronically to the Secretary, who will review them and guide what information should be disseminated to device user facilities and health professionals. Furthermore, the bill introduces a requirement for direct patient notification for specific high-risk devices, including those that are implanted, life-sustaining, or significantly used in pediatric populations. Manufacturers must ensure that recall strategies include instructions for healthcare providers to share critical risk information with affected patients. Failure to adhere to these new electronic notification and patient outreach requirements will be classified as a prohibited act under the Federal Food, Drug, and Cosmetic Act.
This bill, titled the Medical Device Recall Improvement Act of 2025, mandates the creation of an electronic format for medical device recall notifications. Within two years, the Secretary of Health and Human Services must establish this format, requiring manufacturers and importers to submit comprehensive details such as the reason for recall, specific device identifiers, and information tailored for both healthcare professionals and patients. A key provision requires the Secretary to maintain a publicly accessible, downloadable electronic database of all device recall notifications. Manufacturers must submit these notifications electronically to the Secretary, who will review them and guide what information should be disseminated to device user facilities and health professionals. Furthermore, the bill introduces a requirement for direct patient notification for specific high-risk devices, including those that are implanted, life-sustaining, or significantly used in pediatric populations. Manufacturers must ensure that recall strategies include instructions for healthcare providers to share critical risk information with affected patients. Failure to adhere to these new electronic notification and patient outreach requirements will be classified as a prohibited act under the Federal Food, Drug, and Cosmetic Act.