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 C—Responsibilities of Sponsors

21 C.F.R. § 812.42

FDA and IRB approval

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A sponsor shall not begin an investigation or part of an investigation until an IRB and FDA have both approved the application or supplemental application relating to the investigation or part of an investigation.

[46 FR 8957, Jan. 27, 1981]
Notes of Decisions
Cited in 5 cases (2 in the last 5 years), 1993–2024 · leading case: Femrite v. Abbott Nw. Hosp., 568 N.W.2d 535 (Minn. Ct. App. 1997).
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Femrite v. Abbott Nw. Hosp., 568 N.W.2d 535 (Minn. Ct. App. 1997). · cites it 2× “5 (1996) (requiring investigational device to be labeled as such); 21 C.F.R. § 812.42 (1996) (requiring IRB and FDA to approve application before clinical investigation commences); 21 C.”
Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., 96 F.4th 1347 (Fed. Cir. 2024). “20 ; 21 C.F.R. § 812.42 . To receive premarket approval from the FDA, Meril must first apply for and obtain an investigational device exemption, identify clinical investigators to implant the de- vice in human subjects, collect data from those subjects, and then submit the data…”
Konrady v. Oesterling, 149 F.R.D. 592 (D. Minnesota 1993). “21 C.F.R. §§ 812.42 ; 812.60. The FDA approved the IDE application on the device at issue on April 12, 1990.”
Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd. (Fed. Cir. 2024). “20 ; 21 C.F.R. § 812.42 . To receive premarket approval from the FDA, Meril must first apply for and obtain an investigational device exemption, identify clinical investigators to implant the de- vice in human subjects, collect data from those subjects, and then submit the data…”
Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd. (N.D. Cal. 2020). “20; 21 C.F.R. § 812.42 . 2 To receive premarket approval from the FDA, Meril must first apply for and obtain an 3 investigational device exemption (“IDE”) from the FDA, identify clinical investigators to implant 4 the device in human subjects, collect data from those subjects,…”
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