part_subject: "MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS"
subpart_code: "B"
subpart_subject: "Reports and Records"
section_number: "806.40"
section_subject: "Public availability of reports."
cfr_reference: "21 CFR 806.40"
title_name: "Title 21"
title_subject: "Food and Drugs"
parts_covered: "Parts 800 to 1299"
revised_date: "Revised as of April 1, 2019"
publication_date: "As of April 1, 2019"
contains_description: "Containing a codification of documents of general applicability and future effect"
publication_info: "Published by the Office of the Federal Register National Archives and Records Administration as a Special Edition of the Federal Register"
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(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.