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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AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.
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About 200 staff in the FDA’s Center for Devices and Radiological Health were among the 3,500 FDA employees let go in today’s staff reductions. The cuts, which one employee described as a “Manhattan Project” to the center, are already having a major effect on staff morale.
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Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.
AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.