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SUMMARY

Reporting requirements for:

  • Manufacturer
  • Device user facilities
  • Importers

Reporting of:

  • Death
  • Serious injury
  • Malfunctions

Reporting Followups:

  • Complete investigation of each event
  • Develop & Implement reporting procedures
  • Establish & Maintain reporting files
  • Create system for expedited information access for follow-up/FDA inspection

SUMMARY SLIDE

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SLIDES

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