Code of Federal Regulations Title 21. Food and Drugs § 21.803.9 What information from the reports do we disclose to the public?

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

(2) Any personal, medical, and similar information, including the serial number of implanted devices, which would constitute an invasion of personal privacy under § 20.63 of this chapter. However, if a patient requests a report, we will disclose to that patient all the information in the report concerning that patient, as provided in § 20.61 of this chapter;  and

(3) Any names and other identifying information of a third party that voluntarily submitted an adverse event report.

(1) An action brought to enforce section 301(q) of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 331(q)), including the failure or refusal to furnish material or information required by section 519 of the Federal Food, Drug, and Cosmetic Act (21 U.S.C. 360i));

(2) A communication to a manufacturer of a device that is the subject of a report required to be submitted by a user facility under § 803.30;  or

(3) A disclosure to employees of the Department of Health and Human Services, to the Department of Justice, or to the duly authorized committees and subcommittees of the Congress.