[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: 21CFR812.38]



[Page 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.

    (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 Division of 

Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers 

Lane, rm. 1061, Rockville, MD 20852, 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]