Pre-Cert Program Will Start Off Slow With De Novo Framing, But Big Questions Remain
Executive Summary
Several experts suggest FDA is toeing the line in keeping the first stage of its pre-certification program for software-as-a-medical-device products legally permissible, but it may be limited in scope for the time being. Meanwhile, one attorney says the agency is sending mixed messages about whether the current program will sit comfortably within FDA's current authorities.
You may also be interested in...
GOP Senator Wants Time Frame And Other Details On FDA’s AI/ML Action Plan
US Sen. Bill Cassidy says he wants more details about the FDA’s plans to regulate AI/ML medical software, including a time frame for publishing guidance documents.
HHS Advances AI Priorities In Budget Ask
The US Department of Health and Human Services is asking Congress for $10m in its latest budget request specifically to advance the use of artificial intelligence to regulate FDA products and promote development of AI technology. The ask aligns with President Trump’s vision for government agencies to help make the US a leader in AI and machine learning products.
Exec Chat: CES 2020: For FDA's Amy Abernethy, It's About Data, But Also Community Engagement
Amy Abernethy, FDA's principal deputy commissioner, sat down with Medtech Insight during CES 2020 to discuss the agency's progress on the Technology Modernization Action Plan, the pre-certification program for digital health products, and the FDA's plans for 2020.