Title 21

PART 812 SUBPART B

Subpart B - Application and Administrative Action

21:8.0.1.1.9.2.1.1SECTION 812.20
   812.20 Application.
21:8.0.1.1.9.2.1.2SECTION 812.25
   812.25 Investigational plan.
21:8.0.1.1.9.2.1.3SECTION 812.27
   812.27 Report of prior investigations.
21:8.0.1.1.9.2.1.4SECTION 812.28
   812.28 Acceptance of data from clinical investigations conducted outside the United States.
21:8.0.1.1.9.2.1.5SECTION 812.30
   812.30 FDA action on applications.
21:8.0.1.1.9.2.1.6SECTION 812.35
   812.35 Supplemental applications.
21:8.0.1.1.9.2.1.7SECTION 812.36
   812.36 Treatment use of an investigational device.
21:8.0.1.1.9.2.1.8SECTION 812.38
   812.38 Confidentiality of data and information.