US FDA Moves On HDE, IRB, Reprocessing 'Cures' Provisions
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.
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The commissioner explained to senators he is trying to go beyond the 21st Century Cures Act to further encourage development of innovative digital devices.
The trial was the first related to outbreaks of antibiotic-resistant “superbugs” that were linked to improperly cleaned duodenoscopes.
In line with the 21st Century Cures Act, US FDA has finalized a list of class II devices that will no longer need pre-market notification to get to market. Also, check out our updated Cures Act implementation table.