Government Healthcare Policy, Business and Technology

Critics say an increase in fees could hurt smaller firms, including digital health startups.

Modern Healthcare: The hearing comes not long after President Donald Trump released a 2018 budget blueprint doubling the $1 billion in revenue the fees generate, though the administration didn't specify what portion of that would come from medical devices versus pharmaceuticals, the latter historically generating a much larger source of fee revenue. The fees fund ways to expedite the FDA's product approval process and will be pivotal to Trump's promises to reform the agency.

The House Energy and Commerce health subcommittee hosted a hearing on expected changes to the FDA's Medical Device User Fee Admendments program last week. The Advanced Medical Technology Association, which represents devicemakers, is on board with the latest fee package, which CEO Scott Whitaker called a “win-win-win for the FDA, for innovation and most of all, for patients.”

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