00091 REV01 21 CFR Part 812 Investigational Device Exemptions

00091 REV01 21 CFR Part 812 Investigational Device Exemptions

Part 812Investigational Device Exemptions812.1 – 812.150

Subpart A General Provisions 812.1 – 812.19

  • 812.1Scope.
  • 812.2Applicability.
  • 812.3Definitions.
  • 812.5Labeling of investigational devices.
  • 812.7Prohibition of promotion and other practices.
  • 812.10Waivers.
  • 812.18Import and export requirements.
  • 812.19Address for IDE correspondence.

Subpart B Application and Administrative Action  812.20 – 812.38

  • 812.20Application.
  • 812.25Investigational plan.
  • 812.27Report of prior investigations.
  • 812.28Acceptance of data from clinical investigations conducted outside the United States.
  • 812.30FDA action on applications.
  • 812.35Supplemental applications.
  • 812.36Treatment use of an investigational device.
  • 812.38Confidentiality of data and information.

Subpart C  Responsibilities of Sponsors  812.40 – 812.47

  • 812.40General responsibilities of sponsors
  • 812.42FDA and IRB approval.