[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: 21CFR812.43]



[Page 110]

 

                        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]