US Regulatory Reads, May: Program Alignment, FDA On The Hill, Breakthough 510(k)s
Executive Summary
US regulatory and policy topics that attracted the most attention among Medtech Insight readers in May included the launch of FDA's "program alignment" inspectional revamp; progress and debate over FDA's budget, user fees and other potential reforms; and our look at the next steps for FDA's Expedited Access/Breakthrough pathway.