User Facility Reporting Requirements

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Medical Device Reporting
  7. User Facility Reporting Requirements

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Section
803.30

If I am a user facility, what reporting requirements apply to me?

Section
803.32

If I am a user facility, what information must I submit in my individual adverse event reports?

Section
803.33

If I am a user facility, what must I include when I submit an annual report?