[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.38]

[Page 108-109]
 
                        TITLE 21--FOOD AND DRUGS
 
CHAPTER I--FOOD AND DRUG ADMINISTRATION, DEPARTMENT OF HEALTH AND HUMAN 
                          SERVICES (CONTINUED)
 
PART 812--INVESTIGATIONAL DEVICE EXEMPTIONS--Table of Contents
 
            Subpart B--Application and Administrative Action
 
Sec. 812.38  Confidentiality of data and information.

    (a) Existence of IDE. FDA will not disclose the existence of an IDE 
unless its existence has previously been publicly disclosed or 
acknowledged, until FDA approves an application for premarket approval 
of the device subject to the IDE; or a notice of completion of a product 
development protocol for the device has become effective.
    (b) Availability of summaries or data. (1) FDA will make publicly 
available, upon request, a detailed summary of information concerning 
the safety and effectiveness of the device that was the basis for an 
order approving, disapproving, or withdrawing approval of an application 
for an IDE for a banned device. The summary shall include information on 
any adverse effect on health caused by the device.
    (2) If a device is a banned device or if the existence of an IDE has 
been publicly disclosed or acknowledged, data or information contained 
in the file is not available for public disclosure before approval of an 
application for premarket approval or the effective date of a notice of 
completion of a product development protocol except as provided in this 
section. FDA may, in its discretion, disclose a summary of selected 
portions of the safety and effectiveness data, that is, clinical, 
animal, or laboratory studies and tests of the device, for public 
consideration of a specific pending issue.
    (3) If the existence of an IDE file has not been publicly disclosed 
or acknowledged, no data or information in the file are available for 
public disclosure except as provided in paragraphs (b)(1) and (c) of 
this section.

[[Page 109]]

    (4) Notwithstanding paragraph (b)(2) of this section, FDA will make 
available to the public, upon request, the information in the IDE that 
was required to be filed in Docket Number 95S-0158 in the Dockets 
Management Branch (HFA-305), Food and Drug Administration, 12420 
Parklawn Dr., rm. 1-23, Rockville, MD 20857, for investigations 
involving an exception from informed consent under Sec. 50.24 of this 
chapter. Persons wishing to request this information shall submit a 
request under the Freedom of Information Act.
    (c) Reports of adverse effects. Upon request or on its own 
initiative, FDA shall disclose to an individual on whom an 
investigational device has been used a copy of a report of adverse 
device effects relating to that use.
    (d) Other rules. Except as otherwise provided in this section, the 
availability for public disclosure of data and information in an IDE 
file shall be handled in accordance with Sec. 814.9.

[45 FR 3751, Jan. 18, 1980, as amended at 53 FR 11253, Apr. 6, 1988; 61 
FR 51531, Oct. 2, 1996]