21 CFR 806.40
§ 806.40 Public availability of reports.
United States · 21 CFR — Food and Drugs · Status: effective
Cite this
- Citation
- 21 CFR 806.40, § 806.40 Public availability of reports, United States, version 1 as recorded 2026-07-09, yourstate.us, https://yourstate.us/provision/88736
- Permanent ID
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Full text
(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.
Legislative history
This is a federal regulation, adopted through agency rulemaking under the Administrative Procedure Act — not enacted by a recorded vote of Congress.