S. 2503 · 114th Congress
Preventing Superbugs and Protecting Patients Act
- Stage
- Reported from committee
- Sponsor
- Patty Murray
- Introduced
- 2016-02-04
- Latest action
- 2016-04-05 · Committee on Health, Education, Labor, and Pensions. Reported by Senator Alexander with an amendment in the nature of a substitute. Without written report.
Summary
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.