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S. 3416 (117th): Protecting Patients from Counterfeit Medical Devices Act

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The summary below was written by the Congressional Research Service, which is a nonpartisan division of the Library of Congress, and was published on Jan 12, 2023.

Protecting Patients from Counterfeit Medical Devices Act

This bill expands provisions in the Federal Food, Drug, and Cosmetic Act pertaining to counterfeit drugs to also cover counterfeit medical devices and addresses related issues. (Current law prohibits trafficking in counterfeit goods generally.)

The bill prohibits certain actions, such as selling counterfeit devices or forging labels to make counterfeit medical devices. An individual or entity that makes or sells a counterfeit medical device shall be subject to fines, imprisonment for up to 10 years, or both.

Counterfeit medical devices, packaging and labeling for counterfeit medical devices, and items used for making counterfeit medical devices may be seized pursuant to a federal court proceeding.