[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: 21CFR812.110]



[Page 111-112]

 

                        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 E_Responsibilities of Investigators

 

Sec.  812.110  Specific responsibilities of investigators.



    (a) Awaiting approval. An investigator may determine whether 

potential subjects would be interested in participating in an 

investigation, but shall



[[Page 112]]



not request the written informed consent of any subject to participate, 

and shall not allow any subject to participate before obtaining IRB and 

FDA approval.

    (b) Compliance. An investigator shall conduct an investigation in 

accordance with the signed agreement with the sponsor, the 

investigational plan, this part and other applicable FDA regulations, 

and any conditions of approval imposed by an IRB or FDA.

    (c) Supervising device use. An investigator shall permit an 

investigational device to be used only with subjects under the 

investigator's supervision. An investigator shall not supply an 

investigational device to any person not authorized under this part to 

receive it.

    (d) Financial disclosure. A clinical investigator shall disclose to 

the sponsor sufficient accurate financial information to allow the 

applicant to submit complete and accurate certification or disclosure 

statements required under part 54 of this chapter. The investigator 

shall promptly update this information if any relevant changes occur 

during the course of the investigation and for 1 year following 

completion of the study.

    (e) Disposing of device. Upon completion or termination of a 

clinical investigation or the investigator's part of an investigation, 

or at the sponsor's request, an investigator shall return to the sponsor 

any remaining supply of the device or otherwise dispose of the device as 

the sponsor directs.



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