1. Medtech Insight
  2. >>Policy & Regulation

Dx Departure: US FDA's Diagnostics Chief Gutierrez Steps Down

 
• By David Filmore

Alberto Gutierrez left FDA and government this week in a planned retirement. He was director of the office that oversees pre- and post-market programs for in vitro diagnostics and radiology devices, an office where several holes already exist in top management slots.

Diagnostics and radiology device director Alberto Gutierrez left US FDA this week after 25 years at the agency, creating another opening at the top of a diagnostics office that already has multiple vacancies in its management ranks.

Gutierrez led FDA diagnostics policy during a period of substantial reassessment and reform as the agency grappled with the rapidly evolving developments in personalized medicine, genomics and the underlying structure...

Read the full article – start your free trial today!

Join thousands of industry professionals who rely on Medtech Insight for daily insights

  • Start your 7-day free trial
  • Explore trusted news, analysis, and insights
  • Access comprehensive global coverage
  • Enjoy instant access – no credit card required
Start Free Trial

Already a subscriber?

More from Regulation

More from Policy & Regulation

Inclusive By Design: UK Invites Sponsors To Submit Trial Diversity Plans

 
• By Vibha Sharma

The UK has issued clearer guidance to help drug and medical device sponsors demonstrate how they intend to include a diverse and relevant range of participants in their clinical trials.

Plans For Specific EU Orphan And Pediatric Device Expert Panel Need To Go Further

 
• By Amanda Maxwell

Moves are at last underway for a more specific focus on orphan and pediatric devices. They are a start; but experts are calling for more to support this sector.

First Alzheimer’s Disease Diagnostic Blood Test Cleared By FDA

 
• By Natasha Barrow

Fujirebio Diagnostics' Alzheimer's disease test, Lumipulse G pTau217/ß-Amyloid 1-42 Plasma Ratio, has been cleared by the US FDA.