Medical Devices; Guidance on Resolving Scientific Disputes Concerning the Regulation of Medical Devices; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Resolving Scientific Disputes Concerning the Regulation of Medical Devices." The guidance describes the role and operation of the Medical Devices Dispute Resolution Panel of the Medical Devices Advisory Committee (the Dispute Resolution Panel), the types of controversies eligible for review by the Dispute Resolution Panel, and recommendations for submitting a request for review.