21 C.F.R. § 803.16
When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?
No. A report or other information submitted by you, and our release of that report or information, is not necessarily an admission that the device, or you or your employees, caused or contributed to the reportable event. You do not have to admit and may deny that the report or information submitted under this part constitutes an admission that the device, you, or your employees, caused or contributed to a reportable event.
Notes of Decisions
Cited in 4
cases (2 in the last 5 years), 2009–2025 · leading case: Conklin Et Ux v. Medtronic Inc, 431 P.3d 571 (Ariz. 2018).
Conklin Et Ux v. Medtronic Inc, 431 P.3d 571 (Ariz. 2018). “htm [https://perma.cc/E6U4-FMKU] (last updated Sept.”
TMJ Implants, Inc. v. United States Dep't of Health & Human Servs., 584 F.3d 1290 (10th Cir. 2009). “21 C.F.R. § 803.16 . Indeed, the standard form for the submission of an MDR includes a disclaimer to that effect.”
Redick v. Smith & Nephew, Inc. (D. Maryland 2021). “” 21 C.F.R. § 803.16 . While MDRs may be used to establish notice or knowledge or to suggest alternative causes, see Berman v.”
Smith v. Depuy Synthes Inc. (E.D. La. 2025). “117 21 C.F.R. § 803.16 ; see also Pinsonneault v.”
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