[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: 21CFR812.27]



[Page 104]

 

                        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effectiveness of the device, copies of all published and unpublished 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    (2) A summary of all other unpublished information (whether adverse 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]