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FDA 'Cures' Fund Breakdown: Breakthrough Devices, HDEs, IRB Flexibility And More

 
• By Sue Darcey

FDA's device center 'has a lot of work ahead of us,' to implement not only the 21st Century Cures Act, but also maintain performance goals for device and drug reviews, speakers said at a Food Drug Law Institute meeting May 5. The agency released a proposed work plan for use of 'Cures' Innovation Account funds, with dollars detailed for the device side on breakthrough devices, humanitarian device exemptions, and least burdensome device provisions, among others, as spelled out for use at a May 8-9 Science Board meeting.

US FDA's device center has "a lot of work ahead of us" to respond to the new provisions enacted Dec. 13 in the 21st Century Cures Act, says Jonette Foy, acting associate director for policy of FDA's Center for Devices and Radiological Health.

The center, along with the rest of the agency, will rely on additional funds provided by Congress to support implementation of the Cures Act. Foy spoke on a panel May 5 at the Food, Drug Law Institute annual meeting in Washington, DC, about FDA's plans for the Cures reforms. The discussion occurred on the same day that the agency released its proposed FDA

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