[Code of Federal Regulations]
[Title 21, Volume 8]
[Revised as of April 1, 2001]
From the U.S. Government Printing Office via GPO Access
[CITE: 21CFR812.119]

[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. 812.119  Disqualification of a clinical investigator.

    (a) If FDA has information indicating that an investigator has 
repeatedly or deliberately failed to comply with the requirements of 
this part, part 50, or part 56 of this chapter, or has repeatedly or 
deliberately submitted false information either to the sponsor of the 
investigation or in any required report, the Center for Devices and 
Radiological Health will furnish the investigator written notice of the 
matter under complaint and offer the investigator an opportunity to 
explain the matter in writing, or, at the option of the investigator, in 
an informal conference. If an explanation is offered and accepted by the 
Center for Devices and Radiological Health, the disqualification process 
will be terminated. If an explanation is offered but not accepted by the 
Center for Devices and Radiological Health, the investigator will be 
given an opportunity for a regulatory

[[Page 112]]

hearing under part 16 of this chapter on the question of whether the 
investigator is entitled to receive investigational devices.
    (b) After evaluating all available information, including any 
explanation presented by the investigator, if the Commissioner 
determines that the investigator has repeatedly or deliberately failed 
to comply with the requirements of this part, part 50, or part 56 of 
this chapter, or has deliberately or repeatedly submitted false 
information either to the sponsor of the investigation or in any 
required report, the Commissioner will notify the investigator, the 
sponsor of any investigation in which the investigator has been named as 
a participant, and the reviewing IRB that the investigator is not 
entitled to receive investigational devices. The notification will 
provide a statement of basis for such determination.
    (c) Each investigational device exemption (IDE) and each cleared or 
approved application submitted under this part, subpart E of part 807 of 
this chapter, or part 814 of this chapter containing data reported by an 
investigator who has been determined to be ineligible to receive 
investigational devices will be examined to determine whether the 
investigator has submitted unreliable data that are essential to the 
continuation of the investigation or essential to the approval or 
clearance of any marketing application.
    (d) If the Commissioner determines, after the unreliable data 
submitted by the investigator are eliminated from consideration, that 
the data remaining are inadequate to support a conclusion that it is 
reasonably safe to continue the investigation, the Commissioner will 
notify the sponsor who shall have an opportunity for a regulatory 
hearing under part 16 of this chapter. If a danger to the public health 
exists, however, the Commissioner shall terminate the IDE immediately 
and notify the sponsor and the reviewing IRB of the determination. In 
such case, the sponsor shall have an opportunity for a regulatory 
hearing before FDA under part 16 of this chapter on the question of 
whether the IDE should be reinstated.
    (e) If the Commissioner determines, after the unreliable data 
submitted by the investigator are eliminated from consideration, that 
the continued clearance or approval of the marketing application for 
which the data were submitted cannot be justified, the Commissioner will 
proceed to withdraw approval or rescind clearance of the medical device 
in accordance with the applicable provisions of the act.
    (f) An investigator who has been determined to be ineligible to 
receive investigational devices may be reinstated as eligible when the 
Commissioner determines that the investigator has presented adequate 
assurances that the investigator will employ investigational devices 
solely in compliance with the provisions of this part and of parts 50 
and 56 of this chapter.

[62 FR 12096, Mar. 14, 1997]

Subpart F  [Reserved]