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Spurred On By HHS Policy Shift, AdvaMed Chief Wants LDT Reform In User-Fee Negotiations

The medical device advocacy group plans to include laboratory developed test reform in their upcoming user-fee negotiations with the US FDA.

AdvaMed’s Scott Whitaker
ADVAMED CEO SCOTT WHITAKER IN HIS WASHINGTON, DC, OFFICE IN JANUARY • Source: Ferdous Al-Faruque

AdvaMed CEO Scott Whitaker plans to include laboratory developed test reform as part of the upcoming Medical Device User Fee Amendment (MDUFA) negotiations between the US Food and Drug Administration and industry. The decision was spurred on by an August proclamation by the Department of Health and Human Services (HHS), the overseer of the FDA, that the agency lacks authority to regulate LDTs.

LDT oversight has been a controversial and politically charged topic over the past few years. The HHS recently posted to...

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Dermal Fillers For Décolletage May Gain FDA Approval

 
• By Elizabeth Orr

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Planning To Take Part in MDUFA? FDA Wants To Hear From You

 
• By Brian Bossetta

The US FDA needs to know who wants a seat at the MDUFA negotiations table before discussions can begin. The agency is asking stakeholders to let it know if they plan to participate in the periodic consultation meetings before July 28.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 
• By Amanda Maxwell

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

Investors Urged To Prioritize Patient Engagement To Ensure Clients’ Products Succeed

 
• By Amanda Maxwell

To succeed in medtech, investors must focus on patient outcomes. Gilde Healthcare says involving patients boosts product effectiveness, access and market success — making it a smart strategy in today’s strained healthcare systems.

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Global Medtech Guidance Tracker: June 2025

 
• By Vibha Sharma

Stay current on regulatory guidelines from around the world with Medtech Insight's Guidance Tracker. Over 50 documents have been posted on the tracker since its last update.

Finland Cracks Down On Software That Needs Regulating As A Medical Devices

 
• By Amanda Maxwell

Finland has initiated a project to improve the effectiveness of the monitoring of software intended for medical use and to ensure that software placed on its market meets the requirements set for it. 

Novel Pathway For Combined Drug/IVD Trials Wins Backing Of EU Nations

 
• By Vibha Sharma

Broad participation by EU member states in a new pilot to test a unified procedure for evaluating applications for combined drug and IVD studies shows they recognize its value, says Monique Al, vice-chair of the Clinical Trials Coordination Group.