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e-CFR data is current as of March 5, 2021

Title 21Chapter ISubchapter HPart 803Subpart A → §803.9


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?

(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 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.

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