[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2002]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.110]

[Page 111]
 
                        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 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]