Subpart B. 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.