[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2007]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.43]

[Page 115]
 
                        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 C_Responsibilities of Sponsors
 
Sec.  812.43  Selecting investigators and monitors.

    (a) Selecting investigators. A sponsor shall select investigators 
qualified by training and experience to investigate the device.
    (b) Control of device. A sponsor shall ship investigational devices 
only to qualified investigators participating in the investigation.
    (c) Obtaining agreements. A sponsor shall obtain from each 
participating investigator a signed agreement that includes:
    (1) The investigator's curriculum vitae.
    (2) Where applicable, a statement of the investigator's relevant 
experience, including the dates, location, extent, and type of 
experience.
    (3) If the investigator was involved in an investigation or other 
research that was terminated, an explanation of the circumstances that 
led to termination.
    (4) A statement of the investigator's commitment to:
    (i) Conduct the investigation in accordance with the agreement, the 
investigational plan, this part and other applicable FDA regulations, 
and conditions of approval imposed by the reviewing IRB or FDA;
    (ii) Supervise all testing of the device involving human subjects; 
and
    (iii) Ensure that the requirements for obtaining informed consent 
are met.
    (5) Sufficient accurate financial disclosure information to allow 
the sponsor to submit a complete and accurate certification or 
disclosure statement as required under part 54 of this chapter. The 
sponsor shall obtain a commitment from the clinical investigator to 
promptly update this information if any relevant changes occur during 
the course of the investigation and for 1 year following completion of 
the study. This information shall not be submitted in an investigational 
device exemption application, but shall be submitted in any marketing 
application involving the device.
    (d) Selecting monitors. A sponsor shall select monitors qualified by 
training and experience to monitor the investigational study in 
accordance with this part and other applicable FDA regulations.

[45 FR 3751, Jan. 18, 1980, as amended at 63 FR 5253, Feb. 2, 1998]