21 C.F.R. § 806.40 Public availability of reports.
Title 21 - Food and Drugs
(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.
Title 21: Food and Drugs
PART 806—MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
Subpart B—Reports and Records
§ 806.40 Public availability of reports.
