Compliance, Contamination and FDA Compliance

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

Cloudbyz

AUGUST 19, 2024

Food and Drug Administration (FDA), the European Medicines Agency (EMA), and various other national and international organizations oversee the approval, monitoring, and post-market surveillance of medical devices. Compliance with their regulations is mandatory for manufacturers seeking to market their devices globally.

Compliance

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

FDA Law Blog

JANUARY 1, 2024

The FDA compliance data, sorted by category, shows there were 159 Warning Letters issued to drug manufacturers or sponsors during 2023, with 161 issued in calendar year 2022. Summaries of the most striking recently released Warning Letters are included below. Dextrum Laboratories Inc.

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Clinical Research Informer

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

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

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