FDA and Digital Therapeutics

by | Jul 7, 2020 | FDA, Medical Devices, Requirements

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.


1Akili Interactive (n.d.) Science & Technology retrieved on 07/05/2020 from: https://www.akiliinteractive.com/science-and-technology

2FDA (June 2020) Digital Health retrieved on 07/05/2020 from: https://www.fda.gov/medical-devices/digital-health

3FDA (July 2019) Digital Health Software Precertification (Pre-Cert) Program retrieved on 07/05/2020 from: https://www.fda.gov/medical-devices/digital-health/digital-health-software-precertification-pre-cert-program

4FDA (June 2020) FDA Permits Marketing of First Game-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

Madison Green

Madison Green

Director of Technical Operations - Mrs. Green serves as EMMA International’s Director of Technical Operations. She has experience in technical writing, nonconforming product management, issue evaluations, and implementing corrective and preventative actions in the pharmaceuticals and medical device industries. She has experience cross-functionally between R&D, lean manufacturing operations, and RA compliance. Mrs. Green also has academic and work experience with human health-risk engineering controls, physiological biophysics, and clinical research. Mrs. Green holds a Bachelor of Science in Biosystems Engineering with a concentration in Biomedical Engineering from Michigan State University. She is also a Certified Quality Auditor (CQA), and is currently pursuing her M.S. in Quality Management.

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