Shuren: Industry, Not CDRH, Causing Slow Review Cycles

Industry and CDRH are pointing fingers at each other over the cause of too-slow medical device review. At a hearing on Capitol Hill last week, lawmakers questioned the wisdom of giving the FDA any increase in funding because the agency’s review times for medical devices lag so far behind those in Europe. Low- and moderate-risk devices are taking up to two years longer to reach the U.S. market than similar devices going through the European regulatory system, Josh Makower, CEO of the device incubator ExploraMed, said. For higher-risk devices, the discrepancy is greater — the U.S. takes three and a half years, or five times as long as Europe, to grant device approval, on average.
Devices & Diagnostics Letter