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 E—Responsibilities of Investigators

21 C.F.R. § 812.100

General responsibilities of investigators

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An investigator is responsible for ensuring that an investigation is conducted according to the signed agreement, the investigational plan and applicable FDA regulations, for protecting the rights, safety, and welfare of subjects under the investigator's care, and for the control of devices under investigation. An investigator also is responsible for ensuring that informed consent is obtained in accordance with part 50 of this chapter. Additional responsibilities of investigators are described in subpart G.

[45 FR 3751, Jan. 18, 1980, as amended at 46 FR 8957, Jan. 27, 1981]
Notes of Decisions
Cited in 5 cases, 1996–2016 · 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× “See 21 C.F.R. § 812.100 (1996) (requiring "investigator" to obtain informed consent).”
Berish v. Richards Med. Co., 937 F. Supp. 181 (N.D.N.Y. 1996). “60 (composition and duties of institutional review board); 21 C.F.R. § 812.100 (responsibilities of investigators); 21 C.”
Mink v. Smith & Nephew, Inc., 169 F. Supp. 3d 1321 (S.D. Fla. 2016). “Further, 21 C.F.R. § 812.100 requires the investigator, not the manufacturer to obtain the patient’s consent.”
Berish v. Richards Med. Co., 928 F. Supp. 185 (N.D.N.Y. 1996). “60 (composition and duties of institutional review board); 21 C.F.R. § 812.100 (responsibilities of investigators); 21 C.”
Mink v. Smith & Nephew, Inc., 145 F. Supp. 3d 1208 (S.D. Fla. 2015). “See 21 C.F.R. 812.100. Plaintiff also brings a claim, under Count IV, for negligent misrepresentation based on the notion that S & N represented that it would monitor him through the study for a minimum of ten years.”
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