Fierce Medical Devices

July 10, 2012 | By Damian Garde

President Barack Obama signed the FDA Safety and Innovation Act on Monday, reauthorizing the agency and doubling the charge devicemakers will pay for approvals over the next 5 years. The charge comes with the promise of FDA reform, and, at least for now, device groups are optimistic for the future.

The bill sailed through Congress after months of negotiation between the industry and the FDA, and the final text will increase the cost to device firms from $295 million over the last 5 years, to $595 million over the next. In exchange, the FDA has agreed to implement a more predictable, reliable, efficient and expeditious approval process for devices…

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