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US FDA Moves On HDE, IRB, Reprocessing 'Cures' Provisions

 
• By Elizabeth Orr

FDA stepped up efforts to implement the 21st Century Cures Act device provisions with actions to formalize an expansion of the Humanitarian Device Exemption program to include devices treating conditions that affect up to 8,000 patients, increase flexibility for the institutional review board process and specify validation requirements for certain reusable devices.

US FDA moved this week to enact multiple provisions of the 21st Century Cures Act, to expand the Humanitarian Device Exemption (HDE) program, streamline clinical-trial requirements and detail which reusable devices are subject to validation data requirements for some reusable devices.

The actions may reflect a pickup in policymaking from the agency now that Scott Gottlieb is in place as a...

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