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Medical Devices / Inspections and Audits

Gottlieb Highlights Medical Device Initiatives in FY 2019 Budget Hearing

May 2, 2018
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FDA Commissioner Scott Gottlieb featured new agency initiatives for medical devices in remarks to a Senate Appropriations subcommittee on the FDA’s fiscal year 2019 budget request, flagging changes that could lower product development costs and boost safety. 

“The investment you made in the FY 2018 Omnibus budget helps support programs that made 2017 the most successful in the FDA’s history, with a record number of approvals of innovative and generic drugs and novel medical devices,” Gottlieb said, adding that the FY 2019 budget request “builds on these goals.”

Overall, the FY 2019 budget requests $5.8 billion in total resources for FDA, which includes an increase of $473 million in budget authority and $190 million in user fees.

The request includes $100 million to advance the use of real-world experience to inform patient care and provide potentially lower cost ways to develop clinical data to expedite medical product development, he said.

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