Final US Rule On Destroying Noncompliant Import Devices Amended With Prior Notice To Owners

Exercising its power under the Safeguarding Therapeutics Act (STA), the US Food and Drug Administration has issued a final rule authorizing the agency to destroy medical devices valued at $2,500 or less that have been refused entry into the US.

The STA, enacted in January 2021, added a new term – “counterfeit device” – to the Food, Drug, and Cosmetic (FD&C) Act and empowered the FDA to not only keep...