[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2008]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.27]

[Page 112]
 
                        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. 812.27  Report of prior investigations.

    (a) General. The report of prior investigations shall include 
reports of all prior clinical, animal, and laboratory testing of the 
device and shall be comprehensive and adequate to justify the proposed 
investigation.
    (b) Specific contents. The report also shall include:
    (1) A bibliography of all publications, whether adverse or 
supportive, that are relevant to an evaluation of the safety or 
effectiveness of the device, copies of all published and unpublished 
adverse information, and, if requested by an IRB or FDA, copies of other 
significant publications.
    (2) A summary of all other unpublished information (whether adverse 
or supportive) in the possession of, or reasonably obtainable by, the 
sponsor that is relevant to an evaluation of the safety or effectiveness 
of the device.
    (3) If information on nonclinical laboratory studies is provided, a 
statement that all such studies have been conducted in compliance with 
applicable requirements in the good laboratory practice regulations in 
part 58, or if any such study was not conducted in compliance with such 
regulations, a brief statement of the reason for the noncompliance. 
Failure or inability to comply with this requirement does not justify 
failure to provide information on a relevant nonclinical test study.

[45 FR 3751, Jan. 18, 1980, as amended at 50 FR 7518, Feb. 22, 1985]