Manufacturer 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. Manufacturer Reporting Requirements

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Section
803.50

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

Section
803.52

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

Section
803.53

If I am a manufacturer, in which circumstances must I submit a 5-day report?

Section
803.56

If I am a manufacturer, in what circumstances must I submit a supplemental or followup report and what are the requirements for such reports?

Section
803.58

Foreign manufacturers.