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