A bill to establish requirements for reusable medical devices relating to cleaning instructions and validation data, and for other purposes.
Preventing Superbugs and Protecting Patients Act
(Sec. 2) 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.
(Sec. 3) 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.
Referred to the Subcommittee on Health.
Introduced in Senate
Read twice and referred to the Committee on Health, Education, Labor, and Pensions.
Committee on Health, Education, Labor, and Pensions. Ordered to be reported with an amendment in the nature of a substitute favorably.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Placed on Senate Legislative Calendar under General Orders. Calendar No. 417.
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