FDA Expected To Overhaul Device Safety Monitoring
This month, FDA is expected to unveil an improved medical device safety monitoring and reporting program that is aimed at identifying and removing faulty devices from the market earlier. The agency is facing pressure from physicians to strengthen the program after a wave of faulty heart-defibrillator wires were linked to patient injuries and deaths.
- "FDA in Hot Seat on Safety" (Burton, Wall Street Journal, 4/9).