The Journal of mHealth Vol 2 Issue 1 (February 2015) | Page 27

FDA Issues Draft Guidance on General Wellness Devices and Apps

FDA Issues Draft Guidance on
General Wellness Devices and Apps
In January, the FDA issued new draft
guidance documents that outline how
they intend to treat low-risk devices
intended to promote general wellness
with the aim of providing greater clarity on whether, or not, wellness devices
or apps cross over into the area of regulated medical devices. This follows a
commitment in the FDASIA Health IT
Report that was released in April 2014.
The FDA is proposing to not enforce
regulatory compliance for products that
are intended only for general wellness.
These products are designed to maintain
or encourage a general state of health
and may associate a healthy lifestyle with
reducing the risk or impact of certain
diseases or conditions. The hope is that
the policy will foster the development of
low-risk products intended to promote a
healthy lifestyle.
This guidance is of particular relevance
for those developing in the digital health
space. It is therefore well worth reading
the draft documents to gain an understanding of the FDA’s intentions at this
time. As these are draft documents there
will be a period of consultation during
which time the FDA is seeking comments
from stakeholders and the industry. Below
is a summary of the guidance documents:
General Wellness
A general wellness product, for the purposes of the guidance, is described as
having (1) an intended use that relates
to maintaining or encouraging a general
state of health or a healthy activity; or,
(2) an intended use claim that associates
the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and
where it is well understood and accepted
that healthy lifestyle choices may play an
important role in health outcomes for
the disease or condition).
If the product’s intended uses are not
limited to the above general wellness
intended uses, then it is suggested that
the guidance will not apply.
The first category of general wellness

intended uses involve claims about sustaining or offering general improvement
to conditions and functions associated
with a general state of health that do not
make any reference to diseases or conditions. For the purposes of the guidance,
this first category of general wellness
claims relate to:
»» weight management,
»» physical fitness, including products
intended for recreational use,
»» relaxation or stress management,
»» mental acuity,
»» self-esteem (e.g., devices with a cosmetic function that make claims
related only to self-esteem),
»» sleep management, or
»» sexual function.
The FDA provides some examples of
the type of solution that may fall into
these categories:
»» Claims to promote or maintain a
healthy weight, encourage healthy
eating, or assist with weight loss goals;
»» Claims to promote relaxation or
manage stress when there is no reference to anxiety disorders or other
reference to a disease or condition;
»» Claims to increase, improve, or
enhance the flow of qi;
»» Claims to improve mental acuity,
instruction following, concentration, problem solving, multitasking,
resource management, decisionmaking, logic, pattern recognition or
eye-hand coordination;

»» Claims to promote physical fitness,
such as to help log, track, or trend
exercise activity, measure aerobic fitness, improve physical fitness, develop
or improve endurance, strength or
coordination, or improve energy;
»» Claims to promote sleep management, s uch as to track sleep trends;
»» Claims to promote self-esteem, such
as to boost self-esteem;
»» Claims that address a specific body
structure or function, such as to
increase or improve muscle size or body
tone, tone or firm the body or muscle,
enhance cardiac function, or enhance
or improve sexual performance;
»» Claims to improve general mobility or
to assist individuals who are mobility
impaired or who have limited mobility
in a recreational activity; and
»» Claims to enhance an individual’s
participation in recreational activities
by monitoring the consequences of
participating in such activities, such
as to monitor heart rate or monitor
frequency or impact of collisions.
The guidance also includes details of the
types of claims that would not fall into
this category of general wellness:
»» A claim that a product will treat or
diagnose obesity;
»» A claim that a product will treat an
eating disorder, such as anorexia;
»» A claim that a product helps treat
anxiety;
Continued on page 26

The Journal of mHealth

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