FDA Requirements - Class 1 Exempt Medical Device Recall

  • Thread starter TempusVernumProcella
  • Start date


We are restructuring our Class 1/exempt Medical Device Recall Procedure. Some of our products do not fall within FDA regulations as they are used for in vitro environmental testing or are for research use only (yes, they are labeled as such). The current process is very vague. :bonk: Does anyone have suggestions/examples of recall procedures for these types of medical devices?

Gracious thanks! :bigwave:
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