1. Medtech Insight
  2. >>Policy & Regulation
  3. >>Regulation

Podcast: US FDA’s Artificial Intelligence Guidance May Need Congress And Is At Least A Year Away, Expert Says

Zach Rothstein, the top artificial intelligence and machine learning lobbyist at device industry advocacy group AdvaMed, wrote to the US FDA with recommendations on how to regulate AI/ML devices. He sat down with Medtech Insight to break down the topic's most important issues.

AdvaMed's Zach Rothstein working at his office in Washington, D.C. As the top lobbyist for AI/ML, he's working to get US FDA on the same page as industry. • Source: Ferdous Al-Faruque

The US Food and Drug Administration will likely need legislative authority before it goes ahead with any final guidance on medical devices that use artificial intelligence and machine learning, according to Zach Rothstein, VP for technology and regulatory affairs at industry advocacy group AdvaMed. He also says the agency is currently focused on developing the precertification program, which means a guidance on AI/ML is likely at least a year away.

Earlier this year, the FDA published a discussion paper outlining how the agency is thinking about regulating software as a medical device (SaMD) that use AI/ML. Rothstein and more than...

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

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.

MORE Details On MHRA’s Online Platform For Post Market Surveillance

 
• By Ashley Yeo

Post-market surveillance regulations for medtech system users in Great Britain coming into force on 16 June will make new data requirements under new compliance deadlines.

‘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.

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.