The medical device industry is constantly looking for innovative new ways to treat and cure conditions. Last month, the FDA permitted marketing of the first-ever game-based digital therapeutic device aimed at treating children with attention deficit hyperactivity disorder (ADHD). The prescription-only video game, in combination with other treatments, is engineered to create physiological changes in the brain to improve cognitive function...

1. FDA and Digital Therapeutics
By: Madison Wheeler
The medical device industry is constantly looking for innovative new ways to treat and cure
conditions. Last month, the FDA permitted marketing of the first-ever game-based digital
therapeutic device aimed at treating children with attention deficit hyperactivity disorder
(ADHD). The prescription-only video game, in combination with other treatments, is
engineered to create physiological changes in the brain to improve cognitive function.1
EndeavorRx, the name of the game-based device, is the latest example in the growing field of
digital therapeutics.
Digital therapeutics and digital therapies like EndeavorRx are a part of the broad scope of
Digital Health. As innovative new medical device technology is rapidly engineered, the FDA has
established the Digital Health Innovation Action Plan. This plan documents the FDA’s
commitment to several key goals in regards to digital health: Issuing guidance to modernize
policies, increasing the number and expertise of digital health staff at the FDA, and developing
the Digital Health Software Precertification Pilot Program.2 This software precertification
program, also known as the Software Pre-Cert Program, is the foundation of developing a
regulatory model that will provide streamlined and efficient regulatory oversight of software-
based medical devices.3 Through the pre-cert program, software companies can become pre-
certified and would accordingly benefit from a streamlined premarket review process.
EndeavorRx was reviewed through the De Novo premarket review pathway, and its approval
creates a new regulatory classification. With the regulatory classification created, it opens the
door for subsequent devices with the same intended use to follow the 510(k) premarket
notification process and obtain marketing authorization if they demonstrate substantial
equivalence.4 As more ground-breaking digital therapeutics are cleared through the FDA, and
more regulatory classifications are created, consumers can expect to see more of these
innovative devices in the market.
If you are a software company developing a medical device and need regulatory guidance,
EMMA International has the expertise to help. Call 248-987-4497 or email
info@emmainternational.com to get connected with our team of regulatory experts today.
1 Akili Interactive(n.d.) Science & Technology retrieved on 07/05/2020 from:
https://www.akiliinteractive.com/science-and-technology
2 FDA (June 2020) Digital Health retrieved on 07/05/2020 from: https://www.fda.gov/medical-devices/digital-
health
3 FDA (July 2019) Digital Health Software Precertification (Pre-Cert) Programretrieved on 07/05/2020 from:
https://www.fda.gov/medical-devices/digital-health/digital-health-software-precertification-pre-cert-program
4 FDA (June 2020) FDA Permits Marketing of FirstGame-Based Digital Therapeutic to Improve Attention Function in
Children with ADHD retrieved on 07/05/2020 from: https://www.fda.gov/news-events/press-announcements/fda-
permits-marketing-first-game-based-digital-therapeutic-improve-attention-function-children-adhd