Podcast: A Chat With Jeff Shuren – FDA Device Center Chief Worries About Agency Staffing; Talks MDUFA V, Pandemic, More

The head of the US agency’s device center spoke with Medtech Insight in an exclusive wide-ranging interview about his priorities for the future, the nuances of the MDUFA V user-fee negotiations, how COVID-19 has changed the agency, and more.­

Shuren_Jeff_1200
CDRH Director Jeff Shuren speaking at a Reagan-Udall Foundation event in 2019 • Source: Ferdous Al-Faruque

Jeff Shuren, director of the US Food and Drug Administration’s Center for Devices and Radiological Health (CDRH), recently talked to Medtech Insight about lessons learned from the COVID-19 pandemic, warned that some agency staff are only staying on until the crisis is over, and how the Medical Device User Fee Amendments (MDUFA V) negotiations are going.

More from Regulation

Regulatory Experts Alarmed By Credible April Fool’s About US Targeting EU Notified Bodies

 

A seemingly humorous social media post on April Fool’s Day struck a nerve with regulatory experts, reflecting real concerns about recent actions by the US Food and Drug Administration.

US Could Lose Its First Approver Advantage After FDA Layoffs

Mass FDA layoffs on 1 April were designed to spare product reviewers, but still touched many who are critical to the application review process or drug development, which could mean fewer treatments are brought to the US market first.

Staff Cuts At CDRH Focus On Administrative Workers, Spare Reviewers

 

About 200 staff in the FDA’s Center for Devices and Radiological Health were among the 3,500 FDA employees let go in today’s staff reductions. The cuts, which one employee described as a “Manhattan Project” to the center, are already having a major effect on staff morale.

Whitaker Wants Congress To Capitalize On ‘Golden Age Of Medical Innovation’

AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.

More from Policy & Regulation

Global Medtech Guidance Tracker: March 2025

 
• By 

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 40 documents have been posted on the tracker since its last update.

Whitaker Wants Congress To Capitalize On ‘Golden Age Of Medical Innovation’

AdvaMed’s top priorities for the 119th Congress include modernizing US Medicare services and expanding patients’ access to the latest medical technologies.

First At-Home Test For Multiple STIs Gets FDA Clearance

 
• By 

The Visby Medical Women’s Sexual Health Test is the first over-the-counter test cleared by the US Food and Drug Administration to detect chlamydia, gonorrhea and trichomoniasis. It delivers results in about 30 minutes.