FDA draft impact assessment of Federal Performance Standard for Diagnostic X-ray Systems

The proposed amendments to the U.S. performance standard for diagnostic x-ray systems will add requirements for system features that manufacturers of fluoroscopic equipment and major components must meet for newly manufactured systems.

Click here to link to the FDA report produced by the Fluoroscopy Working Group:

http://www.fda.gov/cdrh/radhealth/fluoro/amendxrad.html