FDA medical device regulators’ top priorities over the next three years include improving employee engagement, increasing simplicity and building collaborative communities, according to a new Strategic Priorities paper that FDA’s CDRH released today.
The agency said the priorities further its overall goal of providing Americans with more timely access to the latest high-quality, safe and effective medical devices.
The strategic priorities, in fact, represent a recognition that FDA’s CDRH needs continue to make the medical regulatory process less burdensome if innovation is to take place in the U.S. versus elsewhere. CDRH officials say there is already a growing number of innovators intending to enter the medtech market – and do it in the U.S. market first versus Europe. By the end of 2020, nearly half novel technology makers expect to bring their devices to the U.S. market first or at the same time as other major markets, according to CDRH.
At DeviceTalks Boston, Tyler Shultz will give attendees an inside look at Theranos and how he was able to sound the alarm after he realized the company was falling apart. Shultz will take attendees behind the story that everyone is talking about: the rise and fall of Elizabeth Holmes and her diagnostic company, Theranos.
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