21 C.F.R. § 803.9 What information from the reports do we disclose to the public?
Title 21 - Food and Drugs
(a) We may disclose to the public any report, including any FDA record of a telephone report, submitted under this part. Our disclosures are governed by part 20 of this chapter. (b) Before we disclose a report to the public, we will delete the following: (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. (c) We may not disclose the identity of a device user facility that makes a report under this part except in connection with: (1) An action brought to enforce section 301(q) of the act, including the failure or refusal to furnish material or information required by section 519 of the act; (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.
Title 21: Food and Drugs
PART 803—MEDICAL DEVICE REPORTING
Subpart A—General Provisions
§ 803.9 What information from the reports do we disclose to the public?
