Cert Pilot Program News Today

On my continuing coverage of generative AI used for mental health, I take a look at the latest trends and what is coming down the pike. Get ready for what will happen.

Software is increasingly used as a medical device, transforming the healthcare industry with the goal of improving patient outcomes. However, developing software as a medical device...

On April 3, 2023, the US Food and Drug Administration (FDA) published its draft guidance, Marketing Submission Recommendations for a Predetermined Change Control Plan for Artificial...

Facing novel, swiftly evolving technologies in the digital health space, the US Food and Drug Administration has been trying to balance fostering innovation with providing reasonable...

In September 2022, the U.S. Food & Drug Administration (FDA) released its Clinical Decision Support (CDS) Software Guidance and the final report on the Software Pre-Certification Pilot...

September 2022 will be remembered as a seminal turning point in digital health in the U.S. With the FDA’s final guidance on Clinical...

In the waning days of FDA’s fiscal year, the U.S. Food and Drug Administration (FDA) issued the greatly anticipated final guidance “Clinical Decision Support Software,” which aims to...

FDA Also Issues Report on Software Pre-Cert Pilot, Leaving Unanswered Questions on Future of Software Regulation - Key Points - The Final Guidance does...

In our last post, we took a brief look back through history at FDA's approach to regulating medical device software and found that there is little distinction from the agency's approach to hardware devices.

FDA announced several digital health initiatives aimed at improving the agency’s resources and policies governing software and data systems. We will review FDA’s digital health improvement highlights and take a quick look at AI/ML-enabled medical devices.