[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: 21CFR814.122]

[Page 150]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 814_PREMARKET APPROVAL OF MEDICAL DEVICES--Table of Contents
 
                   Subpart H_Humanitarian Use Devices
 
Sec. 814.122  Confidentiality of data and information.

    (a) Requirement for disclosure. The ``HDE file'' includes all data 
and information submitted with or referenced in the HDE, any IDE 
incorporated into the HDE, any HDE amendment or supplement, any report 
submitted under Sec. 814.126, any master file, or any other related 
submission. Any record in the HDE file will be available for public 
disclosure in accordance with the provisions of this section and part 20 
of this chapter.
    (b) Extent of disclosure. Disclosure by FDA of the existence and 
contents of an HDE file shall be subject to the same rules that pertain 
to PMA's under Sec. 814.9(b) through (h), as applicable.