Regulatory Chokehold on Medtech Innovation?

The U.S. Federal Drug Administration's (FDA) regulatory regime hampers innovation and adversely impacts patient care. Regulatory inefficiencies result in a longer wait for U.S. patients relative to their European counterparts for products made by U.S. medical device firms. For low- and moderate-risk devices, the process to navigate the FDA took companies up to two years longer for approval than for a similar clearance from European regulators. Are your experiences similar to these survey results from more than 200 small- and medium-sized medical tech companies?

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