Alan Atkin, Origin’s Director of Naming recently posted an article about the FDA’s approval of the first game-based digital therapeutic device.
Help for Children Affected by Attention-Deficit Hyperactivity Disorder (ADHD)
FDA approval update; Digital Therapeutics – August 2020.
The following is taken from the FDA announcement 15th June 2020:
‘The FDA reported that it has permitted marketing of the first game-based digital
therapeutic device to improve attention function in children with attention-deficit
hyperactivity disorder (ADHD). The prescription-only game-based device, called
EndeavorRx, is indicated for pediatric patients ages 8 to12 years old with
primarily inattentive or combined-type ADHD who have demonstrated an
Therapeutic Program Aid
The device is intended for use as part of a therapeutic program that can include
clinician-directed therapy, medication, and/or educational programs, which
further address symptoms of the disorder.
“The device offers a non-drug option for improving symptoms associated with
ADHD in children and is an important example of the growing field of digital
therapy and digital therapeutics,” said Jeffrey Shuren, M.D., J.D. Director of the
FDA’s Center for Devices and Radiological Health.
“The FDA is committed to providing regulatory
pathways that enable patients timely access to safe
and effective innovative digital therapeutics.”
New Regulatory Classification
The FDA reviewed the EndeavorRx through the De Novo premarket review
pathway, a regulatory pathway for low to moderate risk devices of a new type.
This action creates a new regulatory classification, which means that subsequent
devices of the same type with the same intended use may go through the FDA’s
premarket notification process, whereby devices can obtain marketing
authorization by demonstrating substantial equivalence to a predicate device.’
Establishing a framework
This follows on from the FDA’s decision in April to allow healthcare companies to
release certain digital therapeutics under a ‘temporary guidance’ designated in
response to the Covid19 crisis. Pear’s schizophrenia therapeutics is one of the
first examples of such a product, albeit with limited availability.
Most recently, the FDA deadline for input into the Digital Health report for the
risks and benefits to health were on the 30th of July.
Digital Healthcare Regulatory Framework
It is anticipated that the outcome of this report will further help to clarify and establish the regulatory
framework for digital healthcare moving forwards. This report is focused on the
software functions excluded from the device definition by the Cures Act. Some of
the key therapeutic aspects include the areas of; encouragement of healthy
lifestyles, electronic patient records and providing limited clinical decision
In addition, we will continue to get updates into the development and
implementation of the FDA’s Digital Health Software Pre-Cert program.