ARTICLE SUMMARY:
Although not a top national debate issue, Senator and presidential candidate Elizabeth Warren is frequently targeting FDA programs for scrutiny that are at the heart of Jeff Shuren’s vision for a more agile medical device regulator. It’s a face-off that could escalate in conjunction with the next user-fee reauthorization.
It looks like a showdown is brewing over how much flexibility FDA should have to try out new regulatory frameworks for medical devices. The stakes could escalate as some of the participants have the potential to rise in political power in the next few years just as the possibility of FDA reforms come to the fore.
