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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 of the clinical laboratory market

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More from Regulation

More from Policy & Regulation

‘Help Us Deregulate’: RFK Announces RFI For Trimming Government Health Agencies

 
• By Brian Bossetta

HHS Secretary Robert F. Kennedy, Jr. is asking the public to help cut waste across the government’s health agencies. Kennedy announced a 60-day comment period allowing the public to take part in a broader federal initiative to reduce regulations and increase transparency.

MedTech Europe’s Bisazza Urges Action As US Tariffs Jeopardize Critical Global Supply Chains

 
• By Amanda Maxwell

The intricate assembly of medical devices, often involving over 1,000 globally sourced components, faces severe disruption due to new US tariffs. These barriers could halt production and devastate small and medium-sized enterprises (SMEs), MedTech Europe’s CEO, Oliver Bisazza, warns in an interview with Medtech Insight.

UK Medtech Regulators Must Ensure Certainty So Businesses Can Plan Their Futures

 
• By Ashley Yeo

With medtech businesses typically managing investment cycles on a three- to five-year basis, local regulatory processes and forward costs of market entry must offer an attractive environment in which companies can plan for growth, says McDermott Will and Emery’s partner and head of healthcare and life sciences, Sharon Lamb. Broad-scale improvements to NICE’s evaluation offerings would similarly enhance the UK’s value to innovators.