[FDA Talk #1] : FDA’s Clinical Decision Support Software Guidance and Its Implications for the Industry
FDA’s regulation of digital health products is continuously evolving to ensure safe and effective products for patients,healthcare professionals, and caregivers, while fostering an environment that encourages innovation for the industry. FDA recently released final guidance for Clinical Decision Support software, which significantly narrowed the scope of the digital health products that are excluded (or exempted) from the “medical device” definition. Software product manufacturers are attempting to understand what this means and to adjust to this change in the regulatory environment. Sung Park and James Segroves provided an overview of FDA’s current regulatory framework, and discussed on what the companies should be thinking about in this constantly changing and evolving environment.