Warren v. Shuren? The Presidential Hopeful Pushes Against Device Director’s Regulatory Outlook

article image

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.

This article is restricted to subscribers only.

To continue reading, select one of the options below:

Existing Subscriber?

Sign In to continue reading.

Need Multi-User Access?

Gain access for your entire organization.

Get Quote Check to see if your company already has access

Subscribe to Market Pathways:

Actionable intelligence exploring the people, challenges, and opportunities impacting the global medtech community.

Subscribe to Market Pathways
Subscribe to ELITE Strategist

Become an ELITE Strategist and unlock access to both MedTech Strategist and MTS Market Pathways.

Subscribe to Elite


We're here to help! Please contact us at: