21 CFR § 803.16 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?

Current through Sep 8, 2026 · Read all of Part 803

⚠ 2 pending changes to Part 803

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.

← § 803.15 How will I know if you require more information about my medical device report?§ 803.17 What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me? →