---
kind: "section"
citation: "21 C.F.R. § 803.9"
title: "21"
number: "803.9"
heading: "What information from the reports do we disclose to the public?"
url: "https://uscodex.org/cfr/21/803.9"
---

# §803.9. What information from the reports do we disclose to the public?

- (a) We may disclose to the public any report, including any FDA record of a telephone report, submitted under this part. Our disclosures are governed by [part 20](/cfr/21/part20.md) of this chapter.
- (b) Before we disclose a report to the public, we will delete the following:
  - (1) Any information that constitutes trade secret or confidential commercial or financial information under [§ 20.61](/cfr/21/20.61.md) of this chapter;
  - (2) Any personal, medical, and similar information, including the serial number of implanted devices, which would constitute an invasion of personal privacy under [§ 20.63](/cfr/21/20.63.md) of this chapter. However, if a patient requests a report, we will disclose to that patient all the information in the report concerning that patient, as provided in [§ 20.61](/cfr/21/20.61.md) of this chapter; and
  - (3) Any names and other identifying information of a third party that voluntarily submitted an adverse event report.
- (c) We may not disclose the identity of a device user facility that makes a report under this part except in connection with:
  - (1) An action brought to enforce [section 301(q)](/cfr/21/301.md?p=q) of the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 331(q)](/usc/21/331.md?p=q)), including the failure or refusal to furnish material or information required by [section 519](/cfr/21/519.md) of the Federal Food, Drug, and Cosmetic Act ([21 U.S.C. 360i](/usc/21/360i.md)));
  - (2) A communication to a manufacturer of a device that is the subject of a report required to be submitted by a user facility under [§ 803.30](/cfr/21/803.30.md); or
  - (3) A disclosure to employees of the Department of Health and Human Services, to the Department of Justice, or to the duly authorized committees and subcommittees of the Congress.

## Notes

### Authority

Authority: 21 U.S.C. 352, 360, 360i, 360j, 371, 374.

### Source

Source: 79 FR 8846, Feb. 14, 2014, unless otherwise noted.