by Evan Sweeney |
President Donald Trump signed a bill reauthorizing the Food and Drug Administration’s user fee agreements for drugs and devices that will fund a new digital health unit and allow the agency to tap into new data sources.
The bill’s signing on Friday came without much fanfare from the White House, which had pushed to increase user fees. But the FDA Reauthorization Act of 2017 easily passed the House and Senate with broad bipartisan support from lawmakers that were eager to get new user fee agreements in place before the current agreements expired in October.
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For the health IT sector, the bill officially authorized the Medical Device User Fee Agreement (MDFUA), codifying several new approaches to digital health. Perhaps most notably, the MDFUA establishes a central digital health unit within the Center for Devices and Radiological Health (CDRH). Earlier this month, an FDA spokesperson confirmed that the agency had begun the recruitment process to bring staff on board to the digital health team, but hadn’t made any new hires.
Efforts to overhaul the agency’s approach to digital health are already well underway with a new software precertification program announced last month, part of a broader Digital Health Innovation Plan that aims to provide clearer regulatory guidance to the industry.
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Jeff Smith, vice president of public policy at the American Medical Informatics Association (AMIA) told FierceHealthcare the organization “fully supports” the new law that will advance the use of health data, improve patient engagement and develop new frameworks for medical devices software.
“The digital health work is exciting, innovative, and a potential game-changer for how FDA regulates this emerging intersection of software and medical devices,” he said in an email. “While there are numerous details to better understand, we are optimistic that recently announced pilot programs will help fill in those gaps.”
JC Scott, chief advocacy officer for AdvaMed also voiced support for the new law and for the new digital health unit that “will help ensure a more structured and consistent approach to the review process for digital health technologies.”
In a blog post published Monday, three FDA administrators, including CDRH Director Jeffrey Shuren, M.D., applauded the passage of the bill, highlighting the support it provides for several advancements including the use of real-world data and a new National Evaluation System for Health Technologies which aims to pull data buried in EHRs and health registries.
