21 C.F.R. · Food and Drugs
21 C.F.R. § 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?

Title 21 C.F.R. ● ACTIVE Primary Source
Regulatory Text

21 C.F.R. § 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?

§ 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? 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.

Source: ecfr.gov · govinfo.gov — public domain Official Source ↗
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BS-CFR21-SEC-8924C7
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REGULATION / FEDERAL-CFR-SECTION
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boisestandard.org
Citation
21 C.F.R. § 803.16
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The regulatory text of 21 C.F.R. § 803.16 is reproduced from the official Code of Federal Regulations as published by the Office of the Federal Register and the National Archives and Records Administration.
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boisestandard.org United States Law CFR Title 21 21 C.F.R. § 803.16