Senators Take Up 'Cures' Least Burdensome Review Provision, Add PMA Postmarket Data Shift

Senators Take Up 'Cures' Least Burdensome Review Provision, Add PMA Postmarket Data Shift-insidehealthpolicy: A Senate bipartisan duo introduced a bill Thursday (June 18) that includes provisions similar to language in the House 21st Century Cures Act aimed at eliminating “burdens” slowing down FDA's consideration of new, innovative medical devices by ensuring agency reviewers use least-burdensome requirements in their review, permit centralized, non-local institutional review boards for device trials, and require FDA to update guidance on Clinical Laboratory Improvements Act (CLIA) waivers. However, the senators go beyond the House language by also allowing for reliance on postmarket information for premarket approval (PMA) devices as part of the least burdensome requirements.