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

 
• By Brian Bossetta

The US FDA has issued a final rule allowing the agency to destroy some medical devices that have been refused entry into the US. The rule takes effect 1 July.

Fake Medical Mask
• Source: Shutterstock

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 counterfeit devices from entering the US but also destroy them. (Also see "Real Or Fake

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