After years of decline, medical device approvals by the FDA have finally begun to hit the gas pedal, according to an interesting report from the California Healthcare Institute (CHI) and Boston Consulting Group (BCG).

In hindsight, it appears the FDA hit bottom in 2010 when approval times averaged a staggering four years longer in the United States than in Europe. Those delays kept proven, life-saving technologies from American patients. And even worse, there’s no evidence the FDA’s snail-like approach to approvals made products used in the United States any more effective or safe.

Congress and the FDA came together in 2012 to find ways to implement and fund new policies designed to improve regulatory clarity, consistency, and predictability. The medical device industry agreed to pay significantly higher user fees to help make it happen. The new approach was collected in the Medical Device User Fee Amendments of 2012 (MDUFA III).

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