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 Part 803 · Medical Device Reporting
§ 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?
Independent copy, not an official legal edition. 21 CFR is a U.S. Government work in the public domain; this text comes from the eCFR and the annual CFR edition, and may lag recent amendments. The authoritative version is on ecfr.gov. Compliome is not affiliated with or endorsed by FDA. Not legal advice.
FDA guidance that cites § 803.16
- Medical Device Reporting for Manufacturers : Guidance for Industry and Food and Drug Administration Staff 8 Nov 2016
- Medical Device Reporting for User Facilities 1 Apr 1996
Amendment history
Federal Register documents that created or amended this section.
- 79 FR 8846 14 Feb 2014