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Regulations last checked for updates: May 14, 2025

Title 21 - Food and Drugs last revised: May 12, 2025
All TitlesTitle 21Chapter IPart 822Subpart G - Subpart G—Records and Reports
  • § 822.31 - What records am I required to keep?
  • § 822.32 - What records are the investigators in my surveillance plan required to keep?
  • § 822.33 - How long must we keep the records?
  • § 822.34 - What must I do with the records if the sponsor of the plan or an investigator in the plan changes?
  • § 822.35 - Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan?
  • § 822.36 - Can you inspect and copy the records related to my postmarket surveillance plan?
  • § 822.37 - Under what circumstances would you inspect records identifying subjects?
  • § 822.38 - What reports must I submit to you?
authority: 21 U.S.C. 331,352,360i,360l,371,374
source: 67 FR 38887, June 6, 2002, unless otherwise noted.
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