The study estimated the economic impact of regulations developed under the MQSA. It evaluated conditions of facilities after implementation of the regulations in order to evaluate whether patient access to quality screening services has been adversely affected. The contractor examined agency data sets as well as other public sources to estimate the effect of regulations on facility closures and patient access. Field contacts were used to discuss impacts with industry experts. Preliminary findings are that the regulations have not adversely affected patient access to high quality mammography screens.
PIC ID: 6080.4
Agency Sponsor: FDA-CDRH, Center for Devices and Radiological Health
Federal Contact: Tucker, Steve, 301-827-5339
Performer: Eastern Research Group, Lexington, MA