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U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

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Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2013]
[CITE: 21CFR803.9]
See Related Information on What information from the reports do we disclose to the public? in CDRH databases



TITLE 21--FOOD AND DRUGS
CHAPTER I--FOOD AND DRUG ADMINISTRATION
DEPARTMENT OF HEALTH AND HUMAN SERVICES
SUBCHAPTER H--MEDICAL DEVICES

PART 803 -- MEDICAL DEVICE REPORTING

Subpart A--General Provisions

Sec. 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 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.

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