21 CFR 803.16 : Food And Drugs (§ 1.1 To Parts 1403-1499) — (Subpart A To Parts 1272-1299) — Food And Drug Administration, Department Of Health And Human Services (Continued) (Subpart A To Parts 1272-1299) — Medical Devices (Subpart A To § 898.14) — Medical Device Reporting (§ 803.1 To § 803.58) — General Provisions (§ 803.1 To § 803.19) — When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?

4 Aug 2016

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.

21 CFR 803.16