# 21 C.F.R. § 803.16 (2026): When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_16

## Section

- **Citation:** 21 C.F.R. § 803.16 (2026)
- **Heading:** When I submit a report, does the information in my report constitute an admission that the device caused or contributed to the reportable event?
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** August 14, 2026
- **Source:** Compiled text
- **Location:** Title 21 CFR: Food and Drugs / Chapter I: FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES / Part 803: MEDICAL DEVICE REPORTING / Subpart A: General Provisions / § 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?

## 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.

## Nearby sections

- [21 C.F.R. § 803.1 (2026) § 803.1   What does this part cover?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_1.md)
- [21 C.F.R. § 803.3 (2026) § 803.3   How does FDA define the terms used in this part?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_3.md)
- [21 C.F.R. § 803.9 (2026) § 803.9   What information from the reports do we disclose to the public?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_9.md)
- [21 C.F.R. § 803.10 (2026) § 803.10   Generally, what are the reporting requirements that apply to me?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_10.md)
- [21 C.F.R. § 803.11 (2026) § 803.11   What form should I use to submit reports of individual adverse events and where do I obtain these forms?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_11.md)
- [21 C.F.R. § 803.12 (2026) § 803.12   How do I submit initial and supplemental or followup reports?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_12.md)
- [21 C.F.R. § 803.13 (2026) § 803.13   Do I need to submit reports in English?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_13.md)
- [21 C.F.R. § 803.15 (2026) § 803.15   How will I know if you require more information about my medical device report?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_15.md)
- [21 C.F.R. § 803.16 (2026) § 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?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_16.md)
- [21 C.F.R. § 803.17 (2026) § 803.17   What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_17.md)
- [21 C.F.R. § 803.18 (2026) § 803.18   What are the requirements for establishing and maintaining MDR files or records that apply to me?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_18.md)
- [21 C.F.R. § 803.19 (2026) § 803.19   Are there exemptions, variances, or alternative forms of adverse event reporting requirements?](https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_19.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_16. Check the current official text before relying on it. Not legal advice.