Study: FDA, CMS device approval times still run long

The U.S. Food and Drug Administration's average PMA approval time for medical devices has never consistently met the 180-day approval time required by law. In another setback, the Centers for Medicare and Medicaid also falls far short, on average, in achieving the same deadline for national coverage decisions, according to a new Health Affairs study cited in DOTmed.com. Researchers reviewed all Class III FDA approvals for premarket device applications from 1995 through 2008. They determined that less than 20% of those PMA applications met the 180-day deadline, even as FDA officials made an effort to work within the timeframe. CMS average approval times improved over the same period, according to the study, but still generally missed the goal, the article notes. Story

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