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FDA End-of-Year Release of Warning Letters Impresses (or Depresses)

FDA Law Blog

Four of the letters addressed failure to comply with drug Current Good Manufacturing Practice regulations, four more stated that the recipients were distributing unapproved drug products, two alleged violations of the Quality System Regulation by medical device manufacturers, and one was addressed to a clinical investigator.

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Comprehensive Guide to Medical Device Safety, Systems, and Regulatory Compliance: FAQ

Cloudbyz

This process includes the following key stages: Risk Assessment: Identifying potential risks associated with the device’s design, production, and use. Answer: The EU Medical Device Regulation (MDR) is a regulation that governs the production and distribution of medical devices in the European Union.