# 21 CFR § 803.15: How will I know if you require more information about my medical device report?

> Federal · Regulations · In force

URL: https://www.frixlaw.com/law-library/statutes/ecfr-21-803.15

## Section

- **Citation:** 21 CFR § 803.15
- **Heading:** How will I know if you require more information about my medical device report?
- **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) We will notify you in writing if we require additional information and will tell you what information we need. We will require additional information if we determine that protection of the public health requires additional or clarifying information for medical device reports submitted to us and in cases when the additional information is beyond the scope of FDA reporting forms or is not readily accessible to us.
(b) In any request under this section, we will state the reason or purpose for the information request, specify the due date for submitting the information, and clearly identify the reported event(s) related to our request. If we verbally request additional information, we will confirm the request in writing.

## 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-21-803.15. Check the current official text before relying on it. Not legal advice.