Subpart G—Records and Reports

Sections

• 822.31
  § 822.31 What records am I required to keep?
• 822.32
  § 822.32 What records are the investigators in my surveillance plan required to keep?
• 822.33
  § 822.33 How long must we keep the records?
• 822.34
  § 822.34 What must I do with the records if the sponsor of the plan or an investigator in the plan changes?
• 822.35
  § 822.35 Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?
• 822.36
  § 822.36 Can you inspect and copy the records related to my postmarket surveillance plan?
• 822.37
  § 822.37 Under what circumstances would you inspect records identifying subjects?
• 822.38
  § 822.38 What reports must I submit to you?