21 CFR § 806.40 - Public availability of reports.

---
identifier: "/us/cfr/t21/s806.40"
source: "ecfr"
legal_status: "authoritative_unofficial"
title: "21 CFR § 806.40 - Public availability of reports."
title_number: 21
title_name: "Food and Drugs"
section_number: "806.40"
section_name: "Public availability of reports."
chapter_name: "FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES"
subchapter_number: "H"
subchapter_name: "MEDICAL DEVICES"
part_number: "806"
part_name: "MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS"
positive_law: false
currency: "2026-04-05"
last_updated: "2026-04-05"
format_version: "1.1.0"
generator: "[email protected]"
authority: "21 U.S.C. 352, 360, 360i, 360j, 371, 374."
regulatory_source: "62 FR 27191, May 19, 1997, unless otherwise noted."
cfr_part: "806"
---


# 806.40 Public availability of reports.

(a) Any report submitted under this part is available for public disclosure in accordance with part 20 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 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 of this chapter or 5 U.S.C. 552(b)(6); provided, that except for the information under § 20.61 of this chapter or 5 U.S.C. 552(b)(4), FDA will disclose to a patient who requests a report all the information in the report concerning that patient.