21 CFR Subpart B
Application and Administrative Action
June 25, 2020
§
812.36
Treatment use of an investigational device
§
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
§
812.38
Confidentiality of data and information