Food and Drugs. Part803:Medical device reporting (Eff. 8-14-15). Section803.16: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 d