[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: 21CFR812.119]



[Page 112-113]

 

                        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 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



[[Page 113]]



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]