Medical device complaints, MDR's, and reports workshop

Dennis Gucciardo spoke on the panel "Part 806 Reports of Removals and Corrections."

The panel discussion covered:

  • Relationships between MDR's, corrections, removals, and recalls
  • What are the key elements of 21 CFR Part 806?
  • What are examples of items that need to be reported?
  • Should you file an 806 if you have a recall or advisory notice?
  • What information needs to be reported?
  • What types of records do companies need to keep?
  • Prior to notifying FDA, what steps should you have taken?
  • What are the dos and don'ts when informing FDA of a product problem?
  • Should you have a different strategy for removals and corrections than for recalls?
  • Read More: Medical device complaints, MDR's & reports workshop

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