[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR806.40]

[Page 58]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES--(Continued)
 
PART 806--MEDICAL DEVICES; REPORTS OF CORRECTIONS AND REMOVALS--Table of Contents
 
                     Subpart B--Reports and Records
 
Sec. 806.40  Public availability of reports.

    (a) Any 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; 
and
    (2) Any personnel, medical, or similar information, including the 
serial numbers of implanted devices, which would constitute a clearly 
unwarranted invasion of personal privacy under Sec. 20.63 of this 
chapter or 5 U.S.C. 552(b)(6); provided, that except for the information 
under Sec. 20.61 of this chapter or 5 U.S.C. 552(b)(4), FDA will 
disclose to a patient who requests a report all the information in the 
report concerning that patient.