Guidance for Industry on Medical Device Appeals and Complaints: A Guidance on Dispute Resolution; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of a guidance document entitled ``Medical Device Appeals and Complaints: A Guidance on Dispute Resolution.'' FDA currently has a myriad of dispute resolution and regulatory appeal processes that manufacturers of medical devices and radiological products can avail themselves of in situations where they disagree with a regulatory decision or action initiated by the agency. The agency's Center for Devices and Radiological Health (CDRH) is making this guidance document available in an effort to clarify these various processes and assist the industry in determining which process or processes are appropriate in a given circumstance.