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- i. Changes in the protocol 21 CFR 812.35
- ii. IDE safety/adverse device effects 21 CFR 812.150(b)
- iii. Withdrawal of IRB approval 21 CFR 812.150(b)
- iv. Withdrawal of FDA approval 21 CFR 812.150(b)
- v. Current investigator list 21 CFR 812.150(b)
- vi. Annual reports 21 CFR 812.150(b)
- vii. Recall and device disposition 21 CFR 812.150(b)
- viii. Discontinuation of an investigation 21 CFR 812.150(b)
- ix. Informed consent 21 CFR 812.150(b)
- x. Financial disclosure reports 21 CFR 812.43
- xi. Correspondence 21 CFR 812.140
- xii. Financial interest 21 CFR 812.140
- xiii. Device records 21 CFR 812.140
- xiv. Case Histories 21 CFR 812.140