Pre-Cert Program Will Start Off Slow With De Novo Framing, But Big Questions Remain
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.
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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.
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.