FDA Regulation of Digital Health Products: Recent Changes By FDA and Congress

Digital health is one of the most explosive areas of innovation with software products aimed at wellness and medical applications. Depending on the intended application, software may meet the FDA’s definition of a medical device and be subject to an extensive set of FDA regulatory requirements. Therefore, Developer Beware! It is critical for innovators to know early in the development cycle whether their software is or is not a medical device and, if so, what regulatory requirements apply so they can accurately plan the time and cost to market. Recent actions by the FDA and Congress in the last two years have dramatically changed the regulatory landscape for digital health products.

During this Lunch & Learn, Carol Pratt, PhD JD, will provide a tutorial on FDA regulation of medical devices and discuss how software can meet the definition of a medical device either as a standalone software or as a component or accessory. Dr. Pratt will then cover how the FDA currently is regulating different categories of health/medical software and will discuss the impact of the 21st Century Cures Act on the FDA’s current regulatory framework for digital health products. The scope of digital health products that Carol will cover includes wearables, mobile medical apps, clinical and patient decision support software, and AI. She also will discuss how the regulatory position of digital health products can affect business and payment models.

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