21 CFR 803.16
§ 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?
United States · 21 CFR — Food and Drugs · Status: effective
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- Citation
- 21 CFR 803.16, § 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?, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88706
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Full text
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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.