Records and Reports

  1. Law
  2. CFR 21
  3. Food and Drugs
  4. Food and Drug Administration, Department of Health and Human Services
  5. Medical Devices
  6. Postmarket Surveillance
  7. Records and Reports

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Section
822.31

What records am I required to keep?

Section
822.32

What records are the investigators in my surveillance plan required to keep?

Section
822.33

How long must we keep the records?

Section
822.34

What must I do with the records if the sponsor of the plan or an investigator in the plan changes?

Section
822.35

Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?

Section
822.36

Can you inspect and copy the records related to my postmarket surveillance plan?

Section
822.37

Under what circumstances would you inspect records identifying subjects?

Section
822.38

What reports must I submit to you?