[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: 21CFR806.40]



[Page 58-59]

 

                        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



[[Page 59]]



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.