Summary: S.2503 — 114th Congress (2015-2016)All Information (Except Text)

Bill summaries are authored by CRS.

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Reported to Senate with amendment(s) (04/05/2016)

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.