[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR803.9]

[Page 48]
 
                        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.