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.
About This Bill
Committee
Latest Action · September 21, 2023
Read twice and referred to the Committee on Health, Education, Labor, and Pensions. (text: CR S4658)
This bill establishes new requirements for how medical device manufacturers must notify the public when they recall dangerous or defective products. The FDA would have two years to create a standardized electronic form that manufacturers must use to report all device recalls, and manufacturers would have six months after that to start using the new system. The electronic notifications would include mandatory information such as the device details, the reason for the recall, unique device identifiers, and specific guidance for patients about health risks and what actions they should take. The bill also requires manufacturers to notify patients who have been treated with recalled devices, particularly for serious devices that are implanted in the body, life-sustaining, or commonly used in children. Additionally, the FDA would maintain a publicly accessible online database of all device recalls. The legislation funds these new requirements with approximately $6.7 million for fiscal year 2024 and smaller amounts in subsequent years, and it makes it illegal for manufacturers to fail to comply with the new notification requirements.
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