[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2004]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.1]

[Page 97-98]
 
                        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.

[[Page 98]]

               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 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]