21 CFR Part 812 - Subpart B - Application and Administrative Action
- § 812.20 Application.
- § 812.25 Investigational plan.
- § 812.27 Report of prior investigations.
- § 812.28 Acceptance of data from clinical investigations conducted outside the United States.
- § 812.30 FDA action on applications.
- § 812.35 Supplemental applications.
- § 812.36 Treatment use of an investigational device.
- § 812.38 Confidentiality of data and information.