[Code of Federal Regulations]

[Title 21, Volume 8]

[Revised as of April 1, 2006]

From the U.S. Government Printing Office via GPO Access

[CITE: 21CFR803.9]



[Page 43]

 

                        TITLE 21--FOOD AND DRUGS

 

CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 

                          SERVICES (CONTINUED)

 

PART 803_MEDICAL DEVICE REPORTING--Table of Contents

 

                      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 Sec.  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 Sec.  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 Sec.  

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 

Sec.  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.