In Brief: Device investigator disqualification
This article was originally published in The Gray Sheet
Executive Summary
Device investigator disqualification: FDA publishes final rule in March 14 Federal Register spelling out criteria for disqualification of researchers from investigational device exemption studies. The reg amends a quirk in the investigational device exemption reg which only permitted FDA's device center to disqualify clinical investigators engaged in intraocular lens trials. The final rule, which contains sections outlining "Grounds for Disqualification," "Notification of Disqualification," "Actions Upon Disqualification," "Reinstatement of a Disqualified Investigator" and "Scope," is similar to investigator disqualification regs for drugs, biologics, and animal drugs, and finalizes a 1993 proposed rule ("The Gray Sheet" June 21, 1993, p. 3)...