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Real Or Fake? FDA Seeks To Clarify The Definitions Of Legitimate Medical Devices And Counterfeit Ones

 
• By Brian Bossetta

The 2020 Safeguarding Therapeutics Act added the term “counterfeit devices” to the US FDA’s lexicon, giving the agency the authority to keep them out of the country or even destroy them.

Counterfeit Goods
• Source: Shutterstock

The US Food and Drug Administration has published a final guidance, “Referencing the Definition of ‘Device’ in the Federal Food, Drug, and Cosmetic Act in Guidance, Regulatory Documents, Communications, and Other Public Documents.” The guidance seeks to clarify the definition of what constitutes a device based on the 2020 Safeguarding Therapeutics Act (STA).

The final document, published on 14 November, replaces a draft guidance the agency issued in December 2021. (Also see "

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