FDA defends record for approving medical devices

Feb 18 2011

The Hill: FDA Challenges Medical Device Approval Comparisons With Europe
The Food and Drug Administration defended its approval process for medical devices during a congressional hearing Thursday and said industry comparisons with Europe are off the mark. Device makers argue that the United States is losing its global competitive edge, in part because the federal approval process is both less predictable and slower than in other countries — about two years slower than in Europe for low- and moderate-risk devices and even longer for riskier devices (Pecquet, 2/17).

CQ HealthBeat: FDA And Medical Device Industry At Odds In Hearing
The head of the Food and Drug Administration center that oversees medical devices passionately defended his agency's speed in reviewing new products and argued for more funding — a plea that some Republicans quickly shot down. ... The ongoing tension between industry critics and the FDA was on vivid display at the hearing. GOP lawmakers and three witnesses complained that the agency is slower than European regulators in approving new medical devices. Republicans repeatedly questioned whether sluggish or inconsistent reviews by regulators are jeopardizing U.S. jobs (Adams, 2/17).