Part 812 — Investigational Device Exemptions
Subpart A — General Provisions
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.