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 B—Application and Administrative Action

21 C.F.R. § 812.20

Application

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(a) Submission. (1) A sponsor shall submit an application to FDA if the sponsor intends to use a significant risk device in an investigation, intends to conduct an investigation that involves an exception from informed consent under § 50.24 of this chapter, or if FDA notifies the sponsor that an application is required for an investigation.

(2) A sponsor shall not begin an investigation for which FDA's approval of an application is required until FDA has approved the application.

(3) A sponsor shall submit a signed “Application for an Investigational Device Exemption” (IDE application), together with accompanying materials in electronic format, to one of the addresses in § 812.19, and if eCopy by registered mail or by hand. Subsequent correspondence concerning an application or a supplemental application shall be submitted in electronic format and if eCopy by registered mail or by hand.

(4)(i) A sponsor shall submit a separate IDE for any clinical investigation involving an exception from informed consent under § 50.24 of this chapter. Such a clinical investigation is not permitted to proceed without the prior written authorization of FDA. FDA shall provide a written determination 30 days after FDA receives the IDE or earlier.

(ii) If the investigation involves an exception from informed consent under § 50.24 of this chapter, the sponsor shall prominently identify on the cover sheet that the investigation is subject to the requirements in § 50.24 of this chapter.

(b) Contents. An IDE application shall include, in the following order:

(1) The name and address of the sponsor.

(2) A complete report of prior investigations of the device and an accurate summary of those sections of the investigational plan described in § 812.25(a) through (e) or, in lieu of the summary, the complete plan. The sponsor shall submit to FDA a complete investigational plan and a complete report of prior investigations of the device if no IRB has reviewed them, if FDA has found an IRB's review inadequate, or if FDA requests them.

(3) A description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and, where appropriate, installation of the device, in sufficient detail so that a person generally familiar with good manufacturing practices can make a knowledgeable judgment about the quality control used in the manufacture of the device.

(4) An example of the agreements to be entered into by all investigators to comply with investigator obligations under this part, and a list of the names and addresses of all investigators who have signed the agreement.

(5) A certification that all investigators who will participate in the investigation have signed the agreement, that the list of investigators includes all the investigators participating in the investigation, and that no investigators will be added to the investigation until they have signed the agreement.

(6) A list of the name, address, and chairperson of each IRB that has been or will be asked to review the investigation and a certification of the action concerning the investigation taken by each such IRB.

(7) The name and address of any institution at which a part of the investigation may be conducted that has not been identified in accordance with paragraph (b)(6) of this section.

(8) If the device is to be sold, the amount to be charged and an explanation of why sale does not constitute commercialization of the device.

(9) A claim for categorical exclusion under § 25.30 or § 25.34 or an environmental assessment under § 25.40.

(10) Copies of all labeling for the device.

(11) Copies of all forms and informational materials to be provided to subjects to obtain informed consent.

(12) Any other relevant information FDA requests for review of the application.

(c) Additional information. FDA may request additional information concerning an investigation or revision in the investigational plan. The sponsor may treat such a request as a disapproval of the application for purposes of requesting a hearing under part 16.

(d) Information previously submitted. Information previously submitted to the Center for Devices and Radiological Health, the Center for Biologics Evaluation and Research, or the Center for Drug Evaluation and Research, as applicable, in accordance with this chapter ordinarily need not be resubmitted, but may be incorporated by reference.

[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8956, Jan. 27, 1981; 50 FR 16669, Apr. 26, 1985; 53 FR 11252, Apr. 6, 1988; 61 FR 51530, Oct. 2, 1996; 62 FR 40600, July 29, 1997; 64 FR 10942, Mar. 8, 1999; 73 FR 49942, Aug. 25, 2008; 84 FR 68339, Dec. 16, 2019]
Notes of Decisions
Cited in 19 cases (2 in the last 5 years), 1995–2024 · leading case: Iacangelo v. Georgetown Univ., 580 F. Supp. 2d 111 (D.D.C. 2008).
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Iacangelo v. Georgetown Univ., 580 F. Supp. 2d 111 (D.D.C. 2008). · cites it 13× “§ 360c(a) and 21 C.F.R. § 812.20 (a)(2)). See generally Plaintiffs’ Objections to Magistrate Judge Kay’s September 17, 2008 Report and Recommendation (“Pis.”
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). · cites it 4× “§ 360j(g)(3); 21 C.F.R. §§ 812.20 , 812.25, 812.27 (1996).”
Momenta Pharm., Inc. v. Teva Pharm. USA Inc., 809 F.3d 610 (Fed. Cir. 2015). · cites it 2× “” 21 C.F.R. § 812.20 (2015). In other words, quality control is “used in the manufac- ture of the device.”
Iacangelo v. Georgetown Univ., 595 F. Supp. 2d 87 (D.D.C. 2009). · cites it 3× “(“FDCA”), and 21 C.F.R. § 812.20 , a regulation intended to implement the investigational device exemption of the FDCA) and Count IX (a negligence per se claim based on violations of 21 C.”
United States v. Endotec, Inc., 563 F.3d 1187 (11th Cir. 2009). “§ 360j(g) as well as 21 C.F.R. § 812.20 . The district court’s own findings of fact intimate that the Appellees manufactured and distributed the B-P Ankle device in violation of the IDE clinical study: Dr.”
Guckin v. Nagle, 259 F. Supp. 2d 406 (E.D. Pa. 2003). “To this end, Curon points out that the testing and investigation of a medical device for which an IDE is granted is conducted under the supervision of an IRB, which operates under the direct control of the FDA and is required by the FDA to determine whether, for example,…”
In Re Cryomedical Sciences, Inc. Sec. Litig., 884 F. Supp. 1001 (D. Maryland 1995). “21 C.F.R. § 812.20 . In the absence of a determination that the device involves significant risk, however, testing can be performed at any medical institution pursuant to an “abbreviated” IDE.”
Chmielewski v. Stryker Sales Corp., 966 F. Supp. 839 (D. Minnesota 1997). “21 C.F.R. § 812.20 . Manufacturers must also submit a written protocol of the study’s methodology, a description of each component, and copies of all labeling and informational materials required for the patient’s consent.”
28 Ucc rep.serv.2d 531, prod.liab.rep. (Cch) P 14,411 Ada M. Martin Harold L. Martin v. Telectronics Pacing Sys., Inc., 70 F.3d 39 (6th Cir. 1995). “§ 360j(g)(3); 21 C.F.R. §§ 812.20 , 812.25, 812.27. The Telectronics Guardian ATP 4210 Implantable Cardioverter-Defibrillator-De-mand Pacemaker (“device”) is an investiga-tional medical device not yet approved by the FDA for general release to the marketplace.”
Iacangelo v. Georgetown Univ., 560 F. Supp. 2d 53 (D.D.C. 2008). “21 C.F.R. § 812.20 (a) ..., by using Histoacryl and its combination Lipiodol in the treatment of Karyn Kerris.”
Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., 96 F.4th 1347 (Fed. Cir. 2024). “§ 360c; 21 C.F.R. § 812.20 ; 21 C.F.R. § 812.42 .”
Isbell v. Medtronic, Inc., 97 F. Supp. 2d 849 (W.D. Tenn. 1998). · cites it 3× “Pursuant to 21 C.F.R. § 812.20 , the manufacturer must submit an application setting forth a complete report of all prior investigations and a “description of the methods, facilities, and controls used for the manufacture, processing, packing, storage, and where appropriate,…”
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— 21 C.F.R. § 812.20(a)(2) — 1 case
Iacangelo v. Georgetown Univ., 580 F. Supp. 2d 111 (D.D.C. 2008). “§ 360c(a) and 21 C.F.R. § 812.20 (a)(2)). See generally Plaintiffs’ Objections to Magistrate Judge Kay’s September 17, 2008 Report and Recommendation (“Pis.”
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