Code of Federal Regulations Title 21. Food and Drugs § 21.806.40 Public availability of reports

(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.