Federal (United States) · Regulations
Subpart B — Application and Administrative Action
8 sections
8 sections
- 21 C.F.R. § 812.20Application.
- 21 C.F.R. § 812.25Investigational plan.
- 21 C.F.R. § 812.27Report of prior investigations.
- 21 C.F.R. § 812.28Acceptance of data from clinical investigations conducted outside the United States.
- 21 C.F.R. § 812.30FDA action on applications.
- 21 C.F.R. § 812.35Supplemental applications.
- 21 C.F.R. § 812.36Treatment use of an investigational device.
- 21 C.F.R. § 812.38Confidentiality of data and information.