# 21 C.F.R. § 803.1 (2026): What does this part cover?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/CFR_T21_P803_S803_1

## Section

- **Citation:** 21 C.F.R. § 803.1 (2026)
- **Heading:** What does this part cover?
- **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 / § 803.1: § 803.1   What does this part cover?

## Text

(a) This part establishes the requirements for medical device reporting for device user facilities, manufacturers, importers, and distributors. If you are a device user facility, you must report deaths and serious injuries that a device has or may have caused or contributed to, establish and maintain adverse event files, and submit summary annual reports. If you are a manufacturer or importer, you must report deaths and serious injuries that your device has or may have caused or contributed to, you must report certain device malfunctions, and you must establish and maintain adverse event files. If you are a manufacturer, you must also submit specified followup. These reports help us to protect the public health by helping to ensure that devices are not adulterated or misbranded and are safe and effective for their intended use. If you are a medical device distributor, you must maintain records (files) of incidents, but you are not required to report these incidents.
(b) This part supplements and does not supersede other provisions of this chapter, including the provisions of part 820 of this chapter.
(c) References in this part to regulatory sections of the Code of Federal Regulations are to chapter I of title 21, unless otherwise noted.

## 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_1. Check the current official text before relying on it. Not legal advice.