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May 24, 2015

What does FDA intend to regulate and what does that mean for my digital health product?

The FDA issued final guidances applicable to digital health products on mobile medical applications (MMA) and medical device data systems (MDDS) in February 2015 and a draft guidance on general wellness products (GWP) in January 2015. The MMA guidance identified mobile apps not subject to FDA regulation, mobile apps subject to “enforcement discretion” but the FDA does not intend to regulate, and mobile medical apps that are FDA regulated medical devices. The GWP guidance designated products that would not be regulated by FDA and the MDDS guidance identified devices that FDA does not intend to enforce compliance.

There is far greater detail in these three guidances than can be succinctly described in this article, but all of these guidances do present a fair amount of flexibility in application and interpretation, which is good for the digital health industry. In summary, the FDA has literally just this year ushered in a completely new approach to regulating (or not regulating) products in a way that is more in line with how products are typically designed today in other mainstream industries, and a lot of credit needs to be given to FDA for recognizing what is practical and impractical for them to regulate in terms of digital health products. The implications for the mobile phone/smart phone industry are pretty profound from the MMA and GWP guidances, but also to the growing wearable space and certain software that falls into one of these categories. The GWP guidance in particular offers some broad utility of digital health products that can be applied to patients living with and tracking specific chronic disease conditions, where it is generally well accepted that these chronic conditions can be benefited by promotion, tracking and encouragement of choices that can reduce risk and help living well with chronic diseases. This is very significant, as treating patients with chronic diseases costs approximately 75% of the medical expenditures every year in the United States.

The advantage for digital health products, whether mobile app, wearable or software, that fall into one of these non-FDA regulated categories, is that it allows for product development lifecycle without the compliance requirements typical of a FDA regulated medical device. This translates into added speed to market and added speed to improved, iterative releases of product, both of which reduce cost and uncertainty while increasing the flexibility to product development and marketing teams, all of which can accelerate the sales and distribution of an app, wearable or software.

Putting all of this together, the appropriately positioned digital health products, which ideally are not FDA regulated, could rapidly impact our health care system in a positive way and help stem the tide of chronic disease costs in particular, all while meaningful improving the lives of the patients using these products with the opportunity for timely iterative improvements.