C.F.R. » Title 21 » CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES › SUBCHAPTER H—MEDICAL DEVICES › PART 812—INVESTIGATIONAL DEVICE EXEMPTIONS › Subpart A—General Provisions

21 C.F.R. § 812.1

Scope

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(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 § 812.30 or considered approved under § 812.2(b) exempts a device from the requirements of the following sections of the Federal Food, Drug, and Cosmetic Act (the act) and the regulations in this chapter 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 § 820.10(c), if applicable (unless the sponsor states an intention to comply with these requirements under § 812.20(b)(3) or § 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; 90 FR 55979, Dec. 4, 2025]
Notes of Decisions
Cited in 29 cases, 1995–2020 · leading case: Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006).
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Riegel v. Medtronic, Inc., 451 F.3d 104 (2d Cir. 2006). · cites it 2× “20 (b)(6)(ii); the manufacturer cannot even conduct such a clinical investigation in the first place without FDA permission, 21 C.F.R. § 812.1 (a). The results of such clinical investigations, 4 Other examples of Class III devices include replacement heart valves and implanted…”
Blinn v. Smith & Nephew Richards, Inc., 55 F. Supp. 2d 1353 (M.D. Fla. 1999). · cites it 4× “” 21 CFR § 812.1 (a). “Although *1356 less rigorous than the PMA, the IDE process subjects manufacturers to a completely different set of complex and comprehensive regulations which sets forth detailed procedures for determining whether inves-tigational devices are safe and…”
United States v. David W. Prigmore, United States v. Lee H. Leichter, United States v. John F. Cvinar, 243 F.3d 1 (1st Cir. 2001). “” 21 C.F.R. § 812.1 (a). An IDE thus permits limited use of an unapproved device for the purpose of collecting human test data.”
In re Cardiac Devices Qui Tam Litig., 221 F.R.D. 318 (D. Conn. 2004). “See 21 C.F.R. § 812.1 (a); 21 U.S.C. § 360j(g).”
Elizabeth & Clifford Kemp v. Medtronic, Inc., 231 F.3d 216 (6th Cir. 2000). “” 21 C.F.R. § 812.1 . Accordingly, a device operating under the IDE exemption need not comply with pre-market approval requirements during the trial period.”
United States Ex Rel. Nowak v. Medtronic, Inc., 806 F. Supp. 2d 310 (D. Mass. 2011). “There are two ways in which to avoid the costly and time-consuming premarketapproval process: the investigational device exception, 21 C.F.R. § 812.1 et seq., and “510(k)” clearance based upon prior approval of a substantially equivalent device, 21 U.”
Berish v. Richards Med. Co., 937 F. Supp. 181 (N.D.N.Y. 1996). · cites it 2× “See 21 C.F.R. § 812.1 (a). 21 C.F.R. § 812.1 (a) states, in relevant part, that IDEs are exempt from the following regulations Misbranding under section 502, registration, listing, and premarket notification under section 510, performance standards under section 514, premarket…”
Femrite v. Abbott Nw. Hosp., 568 N.W.2d 535 (Minn. Ct. App. 1997). · cites it 2× “" 21 C.F.R. § 812.1 (a) (1996). An "investigation" is defined as "a clinical investigation or research involving one or more subjects to determine the safety and effectiveness of a device.”
Ada M. Martin & Harold L. Martin v. Telectronics Pacing Sys., Inc. Tplc, Inc. D/B/A Telectronics Pacing Sys. Telectronics Pty Ltd., 105 F.3d 1090 (6th Cir. 1997). “21 C.F.R. § 812.1 (a). B. Telectronics’ Device The Medtronic device’s exemption from the PMA process by way of the § 510(k) notification process was central to the outcome of Medtronic.”
In Re Cryomedical Sciences, Inc. Sec. Litig., 884 F. Supp. 1001 (D. Maryland 1995). · cites it 2× “21 C.F.R. §§ 812.1 , 814.1(c); 21 U.S.C. §§ 360e(a), 360j(g).”
White v. Stryker Corp., 818 F. Supp. 2d 1032 (W.D. Ky. 2011). “20 (b)(6)(ii); the manufacturer cannot conduct such a clinical investigation in the first place without FDA permission, 21 C.F.R. § 812.1 (a). The results of these clinical investigations are included.”
United States v. Endotec, Inc., 563 F.3d 1187 (11th Cir. 2009). “§ 360j(g)(l); 21 C.F.R. § 812.1 (a). “However, fostering innovation does not require the elimination of all burdens on medical device manufacturers .”
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— 21 C.F.R. § 812.1(a) — 2 cases
William E. Chambers & Beverly Chambers v. Osteonics Corp., 109 F.3d 1243 (7th Cir. 1997).
Lewis v. Intermedics Intraocular, Inc., 19 F. Supp. 2d 625 (E.D. La. 1998).
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