• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

CFR - Code of Federal Regulations Title 21

  • Print
  • Share
  • E-mail
-
New Search
Help | More About 21CFR
[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2015]
[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.

The information on this page is current as of April 1 2015.

For the most up-to-date version of CFR Title 21, go to the Electronic Code of Federal Regulations (eCFR).

-
-