[Code of Federal Regulations] [Title 21, Volume 8] [Revised as of April 1, 2006] From the U.S. Government Printing Office via GPO Access [CITE: 21CFR812.1] [Page 98-99] TITLE 21--FOOD AND DRUGS CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES (CONTINUED) PART 812_INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents Subpart A_General Provisions Sec. 812.1 Scope. Subpart A_General Provisions Sec. 812.1 Scope. 812.2 Applicability. 812.3 Definitions. 812.5 Labeling of investigational devices. 812.7 Prohibition of promotion and other practices. 812.10 Waivers. 812.18 Import and export requirements. 812.19 Address for IDE correspondence. Subpart B_Application and Administrative Action 812.20 Application. 812.25 Investigational plan. 812.27 Report of prior investigations. 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. Subpart C_Responsibilities of Sponsors 812.40 General responsibilities of sponsors. 812.42 FDA and IRB approval. 812.43 Selecting investigators and monitors. 812.45 Informing investigators. 812.46 Monitoring investigations. 812.47 Emergency research under Sec. 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. 812.65 [Reserved] 812.66 Significant risk device determinations. Subpart E_Responsibilities of Investigators 812.100 General responsibilities of investigators. 812.110 Specific responsibilities of investigators. 812.119 Disqualification of a clinical investigator. Subpart F [Reserved] Subpart G_Records and Reports 812.140 Records. 812.145 Inspections. 812.150 Reports. Authority: 21 U.S.C. 331, 351, 352, 353, 355, 360, 360c-360f, 360h- 360j, 371, 372, 374, 379e, 381, 382, 383; 42 U.S.C. 216, 241, 262, 263b- 263n. Source: 45 FR 3751, Jan. 18, 1980, unless otherwise noted. (a) The purpose of this part is to encourage, to the extent consistent with the protection of public health and safety and with ethical standards, the discovery and development of useful devices intended for human use, and to that end to maintain optimum freedom for scientific investigators in their pursuit of this purpose. This part provides procedures for the conduct of clinical investigations of devices. An approved investigational device exemption (IDE) permits a device that otherwise would be required to comply with a performance standard or to have premarket approval to be shipped lawfully for the purpose of conducting investigations of that device. An IDE approved under Sec. 812.30 or considered approved under Sec. 812.2(b) exempts a device from the requirements of the following sections of the Federal Food, Drug, and Cosmetic Act (the act) and regulations issued thereunder: Misbranding under section 502 of the act, registration, listing, and premarket notification under section 510, performance standards under section 514, premarket approval under section 515, a banned device regulation under section 516, records and reports [[Page 99]] under section 519, restricted device requirements under section 520(e), good manufacturing practice requirements under section 520(f) except for the requirements found in Sec. 820.30, if applicable (unless the sponsor states an intention to comply with these requirements under Sec. 812.20(b)(3) or Sec. 812.140(b)(4)(v)) and color additive requirements under section 721. (b) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted. [45 FR 3751, Jan. 18, 1980, as amended at 59 FR 14366, Mar. 28, 1994; 61 FR 52654, Oct. 7, 1996]