Taking the Pulse of Medical Device Regulation & Innovation

In 2011, as industry, the U.S. Food & Drug Administration (FDA), Congress and other stakeholders prepared to renew the medical device user fee program, California Healthcare Institute (CHI) and The Boston Consulting Group (BCG) initiated the Competitiveness and Regulation study, which analyzed trends in FDA product review processes and their impact on the medical technology innovation ecosystem. The study was initiated in response to increasingly unpredictable timelines at the Agency and the global financial meltdown, which were undermining U.S. medical technology investment, innovation and competitiveness.

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