To establish requirements for reusable medical devices relating to cleaning instructions and validation data, and for other purposes.
Preventing Superbugs and Protecting Patients Act
This bill amends the Federal Food, Drug, and Cosmetic Act to require the Food and Drug Administration (FDA) to identify types of medical devices for which premarket notification must include proposed labeling, including validated instructions regarding cleaning, disinfection, and sterilization.
The FDA must issue final guidance regarding when a premarket notification is required for a modification to a medical device.Became Public Law No: 114-255.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 417.
Introduced in House
Introduced in House
Referred to the House Committee on Energy and Commerce.
Referred to the Subcommittee on Health.
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