A sponsor, investigator, or any person acting for or on behalf of a sponsor or investigator shall not:
(a) Promote or test market an investigational device, until after FDA has approved the device for commercial distribution.
(b) Commercialize an investigational device by charging the subjects or investigators for a device a price larger than that necessary to recover costs of manufacture, research, development, and handling.
(c) Unduly prolong an investigation. If data developed by the investigation indicate in the case of a class III device that premarket approval cannot be justified or in the case of a class II device that it will not comply with an applicable performance standard or an amendment to that standard, the sponsor shall promptly terminate the investigation.
(d) Represent that an investigational device is safe or effective for the purposes for which it is being investigated.
Notes of Decisions
Eli Lilly & Co. v. Medtronic, Inc., 496 U.S. 661 (1990).
· cites it 2× “39-42; see also 21 CFR § 812.7 (b) (1989) (permitting manufacturers to recover their costs in clinical trials).”
Telectronics Pacing Sys., Inc. v. Ventritex, Inc., 982 F.2d 1520 (Fed. Cir. 1992).
· cites it 3× “21 C.F.R. § 812.7 (1989). 2. All of the other Ventritex activities that Telectronics complains of — presenting clinical trial data at a cardiology conference, reporting clinical trial progress to investors, analysts and journalists, and describing clinical trial results in a…”
US Ex Rel. Bennett v. Medtronic, Inc., 747 F. Supp. 2d 745 (S.D. Tex. 2010).
“27, ¶ 85); see 21 C.F.R. § 812.7 (a). The relators allege facts showing disagreement and uncertainty in the medical community about surgical ablation’s efficacy in treating atrial fibrillation.”
Nexell Therapeutics, Inc. v. Amcell Corp., 143 F. Supp. 2d 407 (D. Del. 2001).
· cites it 4× “Pursuant to 21 C.F.R. § 812.7 , Am-Cell provides the CD34 clinical reagent kits to the investigators on a cost recovery basis.”
Baker v. Danek Med., 35 F. Supp. 2d 865 (N.D. Fla. 1998).
“21 C.F.R. § 812.7 (a), (d). 7 . Pursuant to the contracts, Danek paid the surgeons and engineers more than $15 million in cash and gave them options to buy more than 245,000 shares of Danek stock.”
Nexell Therapeutics, Inc. v. AmCell Corp., 199 F. Supp. 2d 197 (D. Del. 2002).
· cites it 2× “We also remind you that 21 C.F.R. 812.7 prohibits promotion and commercialization of an investiga-tional device or representing that an investigational device is safe or effective for the purposes for which it is being investigated.”
Elliott-Lewis v. Abbott Labs., Inc. (D. Mass. 2019).
· cites it 2× “On March 2, Plaintiff emailed Curcio about what she called “key events surrounding Abbott Vascular’s evolving tolerance for noncompliance in the form of medical device off-label promotion (reference Code of Federal Regulations under 21CFR812.7) and pre-approval promotion…”
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