# 21 CFR § 803.12: How do I submit initial and supplemental or followup reports?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-803.12

## Section

- **Citation:** 21 CFR § 803.12
- **Heading:** How do I submit initial and supplemental or followup reports?
- **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) Manufacturers and importers must submit initial and supplemental or followup reports to FDA in an electronic format that FDA can process, review, and archive.
(b) User facilities that submit their reports and additional information to FDA electronically must use an electronic format that FDA can process, review, and archive. User facilities that submit their reports to FDA on paper must submit any written report or additional information required under this part to FDA, CDRH, Medical Device Reporting, P.O. Box 3002, Rockville, MD 20847-3002, using Form FDA 3500A. Each report must be identified (e.g., “User Facility Report” or “Annual Report”).
(c) If you are confronted with a public health emergency, this can be brought to FDA's attention by contacting FDA's Office of Crisis Management, Emergency Operations Center by telephone, 24-hours a day, at 301-796-8240 or toll free at 866-300-4374, followed by the submission of an email to: emergency.operations@fda.hhs.gov.
Note:
This action does not satisfy your obligation to report under part 803.
(d) You may submit a voluntary telephone report to the MedWatch office at 800-FDA-1088. You may also obtain information regarding voluntary reporting from the MedWatch office at 800-FDA-1088. You may also find the voluntary Form FDA 3500 and instructions to complete it at: http://www.fda.gov/Safety/MedWatch/HowToReport/DownloadForms/default.htm.

## 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-21-803.12. Check the current official text before relying on it. Not legal advice.