21 CFR
Part 812 Investigational Device Exemptions
Subpart A - General Provisions
- § 812.1 Scope
- § 812.2 Applicability 19 × 483
- § 812.3 Definitions
- § 812.5 Labeling of investigational devices 5 × 483
- § 812.7 Prohibition of promotion and other practices 16 × 483
- § 812.10 Waivers
- § 812.18 Import and export requirements 2 × 483
- § 812.19 Address for IDE correspondence
Subpart B - Application and Administrative Action
- § 812.20 Application 3 × 483
- § 812.25 Investigational plan 19 × 483
- § 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 5 × 483
- § 812.36 Treatment use of an investigational device 6 × 483
- § 812.38 Confidentiality of data and information
Subpart C - Responsibilities of Sponsors
- § 812.40 General responsibilities of sponsors 117 × 483
- § 812.42 FDA and IRB approval 8 × 483
- § 812.43 Selecting investigators and monitors 85 × 483
- § 812.45 Informing investigators 4 × 483
- § 812.46 Monitoring investigations 36 × 483
- § 812.47 Emergency research under § 50.24 of this chapter
Subpart D - IRB Review and Approval
- § 812.60 IRB composition, duties, and functions
- § 812.62 IRB approval
- § 812.64 IRB's continuing review
- § 812.66 Significant risk device determinations 5 × 483
Subpart E - Responsibilities of Investigators
- § 812.100 General responsibilities of investigators 374 × 483
- § 812.110 Specific responsibilities of investigators 364 × 483
- § 812.119 Disqualification of a clinical investigator
Subpart G - Records and Reports
- § 812.140 Records 671 × 483
- § 812.145 Inspections
- § 812.150 Reports 114 × 483