What process is FDA currently following to arrive at a decision on a request for approval of an alternative requirement?
When a request is received, a staff member or members are assigned to review it to determine if it meets the criteria for approval established in 900.18(c). This individual or group may also consult with experts in other parts of FDA, with members of the National Mammography Quality Assurance Advisory Committee, and with FDA's Office of the Chief Counsel. The end result of this review is a recommendation to the Chief of the Program Management Branch that the request be accepted, rejected, or that more information be requested before a decision is made. If the Chief of the Program Management Branch agrees, the recommendation is sent to the Director of the Division of Mammography Quality Standards for the final decision. The Branch Chief and/or the Division Director may also seek information from additional scientific or legal experts to aid in making their decisions.