---
kind: "section"
citation: "21 C.F.R. § 806.40"
title: "21"
number: "806.40"
heading: "Public availability of reports."
url: "https://uscodex.org/cfr/21/806.40"
---

# §806.40. Public availability of reports.

- (a) Any report submitted under this part is available for public disclosure in accordance with [part 20](/cfr/21/part20.md) of this chapter.
- (b) Before public disclosure of a report, FDA will delete from the report:
  - (1) Any information that constitutes trade secret or confidential commercial or financial information under [§ 20.61](/cfr/21/20.61.md) of this chapter; and
  - (2) Any personnel, medical, or similar information, including the serial numbers of implanted devices, which would constitute a clearly unwarranted invasion of personal privacy under [§ 20.63](/cfr/21/20.63.md) of this chapter or [5 U.S.C. 552(b)(6)](/usc/5/552.md?p=b-6); provided, that except for the information under [§ 20.61](/cfr/21/20.61.md) of this chapter or [5 U.S.C. 552(b)(4)](/usc/5/552.md?p=b-4), FDA will disclose to a patient who requests a report all the information in the report concerning that patient.

## Notes

### Authority

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

### Source

Source: 62 FR 27191, May 19, 1997, unless otherwise noted.