[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2005]
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  Public availability of reports.

    (a) Any report, including any FDA record of a telephone report, 
submitted under this part is available for public disclosure in 
accordance with part 20 of this chapter.
    (b) Before public disclosure of a report, FDA will delete from the 
report:
    (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. FDA will disclose 
to a patient who requests a report, 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 
voluntarily submitting an adverse event report.
    (c) FDA may not disclose the identity of a device user facility 
which 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 which is the 
subject of a report required 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.

[60 FR 63597, Dec. 11, 1995, as amended at 65 FR 4119, Jan. 26, 2000]

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