21 CFR Subpart G
Records and Reports
June 25, 2020
§
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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