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?