21 C.F.R. § 812.40
General responsibilities of sponsors
Sponsors are responsible for selecting qualified investigators and providing them with the information they need to conduct the investigation properly, ensuring proper monitoring of the investigation, ensuring that IRB review and approval are obtained, submitting an IDE application to FDA, and ensuring that any reviewing IRB and FDA are promptly informed of significant new information about an investigation. Additional responsibilities of sponsors are described in subparts B and G.
Notes of Decisions
Cited in 4
cases (2 in the last 5 years), 1992–2024 · leading case: Telectronics Pacing Sys., Inc. v. Ventritex, Inc., 982 F.2d 1520 (Fed. Cir. 1992).
Telectronics Pacing Sys., Inc. v. Ventritex, Inc., 982 F.2d 1520 (Fed. Cir. 1992). “21 C.F.R. § 812.40 (1989). The fact that some non-physicians may have seen the device at the conferences is merely incidental and of minimal import, since only physicians can implant the device.”
Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd., 96 F.4th 1347 (Fed. Cir. 2024). “And here, it is undisputed that TCTC was attended by many potential clinical investiga- tors.”
Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd. (Fed. Cir. 2024). “And here, it is undisputed that TCTC was attended by many potential clinical investiga- tors.”
Edwards Lifesciences Corp. v. Meril Life Sciences Pvt. Ltd. (N.D. Cal. 2020). “2d at 1523 26 (citing 21 C.F.R. § 812.40 ). “[Meril’s] intent or alternative uses are irrelevant to its qualification 27 to invoke the section 271(e)(1) shield.”
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