# 21 CFR § 803.10: Generally, what are the reporting requirements that apply to me?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-803.10

## Section

- **Citation:** 21 CFR § 803.10
- **Heading:** Generally, what are the reporting requirements that apply to me?
- **Jurisdiction:** Federal
- **Kind:** Regulations
- **Status:** In force
- **Text as of:** September 22, 2026
- **Source:** Publisher's official text
- **Location:** Title 21—Food and Drugs > CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES > SUBCHAPTER H—MEDICAL DEVICES > PART 803—MEDICAL DEVICE REPORTING > Subpart A—General Provisions

## Text

(a) If you are a device user facility, you must submit reports (described in subpart C of this part), as follows:
(1) Submit reports of individual adverse events no later than 10 work days after the day that you become aware of a reportable event:
(i) Submit reports of device-related deaths to us and to the manufacturer, if known, or
(ii) Submit reports of device-related serious injuries to the manufacturers or, if the manufacturer is unknown, submit reports to us.
(2) Submit annual reports (described in § 803.33) to us.
(b) If you are an importer, you must submit reports (described in subpart D of this part), as follows:
(1) Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable event:
(i) Submit reports of device-related deaths or serious injuries to us and to the manufacturer or
(ii) Submit reports of device-related malfunctions to the manufacturer.
(2) [Reserved]
(c) If you are a manufacturer, you must submit reports (described in subpart E of this part) to us, as follows:
(1) Submit reports of individual adverse events no later than 30 calendar days after the day that you become aware of a reportable death, serious injury, or malfunction.
(2) Submit reports of individual adverse events no later than 5 work days after the day that you become aware of:
(i) A reportable event that requires remedial action to prevent an unreasonable risk of substantial harm to the public health or
(ii) A reportable event for which we made a written request.
(3) Submit supplemental reports if you obtain information that you did not submit in an initial report.

## Nearby sections

- [21 CFR § 803.1 § 803.1 What does this part cover?](https://www.frixlaw.com/law-library/statutes/ecfr-21-803.1.md)
- [21 CFR § 803.3 § 803.3 How does FDA define the terms used in this part?](https://www.frixlaw.com/law-library/statutes/ecfr-21-803.3.md)
- [21 CFR § 803.9 § 803.9 What information from the reports do we disclose to the public?](https://www.frixlaw.com/law-library/statutes/ecfr-21-803.9.md)
- [21 CFR § 803.10 § 803.10 Generally, what are the reporting requirements that apply to me?](https://www.frixlaw.com/law-library/statutes/ecfr-21-803.10.md)
- [21 CFR § 803.11 § 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/ecfr-21-803.11.md)
- [21 CFR § 803.12 § 803.12 How do I submit initial and supplemental or followup reports?](https://www.frixlaw.com/law-library/statutes/ecfr-21-803.12.md)
- [21 CFR § 803.13 § 803.13 Do I need to submit reports in English?](https://www.frixlaw.com/law-library/statutes/ecfr-21-803.13.md)
- [21 CFR § 803.15 § 803.15 How will I know if you require more information about my medical device report?](https://www.frixlaw.com/law-library/statutes/ecfr-21-803.15.md)
- [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?](https://www.frixlaw.com/law-library/statutes/ecfr-21-803.16.md)
- [21 CFR § 803.17 § 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/ecfr-21-803.17.md)
- [21 CFR § 803.18 § 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/ecfr-21-803.18.md)
- [21 CFR § 803.19 § 803.19 Are there exemptions, variances, or alternative forms of adverse event reporting requirements?](https://www.frixlaw.com/law-library/statutes/ecfr-21-803.19.md)
- [21 CFR § 803.20 § 803.20 How do I complete and submit an individual adverse event report?](https://www.frixlaw.com/law-library/statutes/ecfr-21-803.20.md)
- [21 CFR § 803.21 § 803.21 Where can I find the reporting codes for adverse events that I use with medical device reports?](https://www.frixlaw.com/law-library/statutes/ecfr-21-803.21.md)

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Source: Frix Law Library, https://www.frixlaw.com/law-library/statutes/ecfr-21-803.10. Check the current official text before relying on it. Not legal advice.