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§ 806.40 - Public availability of reports.

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Any report submitted under this part is available for public disclosure in accordance with part 20 of this chapter.

Before public disclosure of a report, FDA will delete from the report:

Any information that constitutes trade secret or confidential commercial or financial information under § 20.61 of this chapter; and

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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§ 806.30 - FDA access to records.
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