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Senate Draft Bill Compromises On Profit Incentive For Humanitarian Devices

More devices approved under a humanitarian device exemption could be priced for profit if draft Senate language is enacted, but restrictions are included to ensure that current pediatric incentives are not gutted.

The Senate draft legislation for FDA user fee reauthorization, released March 16, includes a compromise to expand the profit incentive for humanitarian-use devices in response to concerns from advocates for pediatric device development.

The device section of the bipartisan draft legislation from the Senate Health, Labor, Education & Pensions Committee includes several provisions that aim to streamline or add incentives to...

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