GroundRules
21 CFR 806.40: Public availability of reports.
Where this section sits in the code
- Title 21—Food and Drugs
- CHAPTER I—FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN SERVICES
- SUBCHAPTER H—MEDICAL DEVICES
- PART 806—MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS
- Subpart B—Reports and Records
(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.
Collected 2026-08-27T02:24:47Z. Source file · JSON