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U.S. Code of Federal Regulations

Regulations most recently checked for updates: Aug 29, 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?
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