IDE Regulations
Regulations pertaining to the Investigational Device Exemptions (IDE)
- 21 CFR 812 - Investigational Device Exemptions
- 21 CFR 50 - Protection of Human Subjects
- 21 CFR 56 - Institutional Review Boards
- 21 CFR 54 - Financial Disclosure by Clinical Investigators
- 21 CFR 58 – Good Laboratory Practice for Nonclinical Laboratory Studies
- 21 CFR 820 - Quality System Regulation