PART 822 SUBPART G
Subpart G - Records and Reports
- 21 U.S.C. 331, 352, 360i, 360l, 371, 374.
- 67 FR 38887, June 6, 2002, unless otherwise noted.
|21:126.96.36.199.188.8.131.52||SECTION 822.31||822.31 What records am I required to keep|
|21:184.108.40.206.220.127.116.11||SECTION 822.32||822.32 What records are the investigators in my surveillance plan required to keep|
|21:18.104.22.168.22.214.171.124||SECTION 822.33||822.33 How long must we keep the records|
|21:126.96.36.199.188.8.131.52||SECTION 822.34||822.34 What must I do with the records if the sponsor of the plan or an investigator in the plan changes|
|21:184.108.40.206.220.127.116.11||SECTION 822.35||822.35 Can you inspect my manufacturing site or other sites involved in my postmarket surveillance plan|
|21:18.104.22.168.22.214.171.124||SECTION 822.36||822.36 Can you inspect and copy the records related to my postmarket surveillance plan|
|21:126.96.36.199.188.8.131.52||SECTION 822.37||822.37 Under what circumstances would you inspect records identifying subjects|
|21:184.108.40.206.220.127.116.11||SECTION 822.38||822.38 What reports must I submit to you|