21 CFR Part 806 · Medical Devices; Reports of Corrections and Removals

§ 806.40 Public availability of reports

Subpart B - Reports and Records Official text on eCFR Amendment history

(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.

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Amendment history

Federal Register documents that created or amended this section.