Document issued on September 27, 2019.
Document originally issued on July 29, 2016.
I. Introduction
The Food and Drug Administration (FDA) is issuing this guidance document to provide
clarity to industry and FDA staff on the Center for Devices and Radiological Health’s
(CDRH’s) compliance policy for low risk products that promote a healthy lifestyle (general
wellness products).1 This guidance does not apply to products (e.g., drugs, biologics, dietary
supplements, foods, or cosmetics) regulated by other FDA Centers or to combination
products.2
Section 3060(a) of the 21st Century Cures Act (Cures Act) amended section 520 of the
Federal Food, Drug, and Cosmetic Act (FD&C Act) on December 13, 2016, removing
certain software functions, including those intended for maintaining or encouraging a healthy
lifestyle that are unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a
disease or condition, from the definition of device in section 201(h) of the FD&C Act.
Section 520(o)(1)(B) of the FD&C Act, states that software that is intended “for maintaining
or encouraging a healthy lifestyle and is unrelated to the diagnosis, cure, mitigation,
prevention, or treatment of a disease or condition” is not a device under section 201(h) of the
FD&C Act.
This guidance clarifies FDA’s interpretation of this provision and its application to general
wellness products.
FDA's guidance documents, including this guidance, do not establish legally enforceable
responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and
should be viewed only as recommendations, unless specific regulatory or statutory
requirements are cited. The use of the word should in Agency guidance means that
something is suggested or recommended, but not required.
II. Policy on Low Risk General Wellness Products
CDRH does not intend to examine low risk general wellness products to determine whether
they are devices3 within the meaning of the FD&C Act or, if they are devices, whether they
comply with the premarket review and post-market regulatory requirements for devices
under the FD&C Act and implementing regulations, including, but not limited to: registration
and listing and premarket notification requirements (21 CFR Part 807); labeling requirements
(21 CFR Part 801 and 21 CFR 809.10); good manufacturing practice requirements as set
forth in the Quality System regulation (21 CFR Part 820); and Medical Device Reporting
(MDR) requirements (21 CFR Part 803).
For purposes of this guidance, CDRH defines general wellness products as products that
meet the following two factors: (1) are intended for only general wellness use, as defined in
this guidance, and (2) present a low risk to the safety of users and other persons. General
wellness products may include exercise equipment, audio recordings, video games, software
programs4
and other products that are commonly, though not exclusively, available from
retail establishments (including online retailers and distributors that offer software to be
directly downloaded), when consistent with the two factors above.
CDRH regularly receives inquiries about whether particular products are devices as defined
by the FD&C Act. There are instances where certain general wellness products, as discussed
in this guidance, do not meet the definition of a device under section 201(h) of the FD&C
Act and therefore are not subject to the FD&C Act’s regulatory requirements for devices.
Additionally, section 520(o)(1)(B) of the FD&C Act excludes software functions that are
intended for maintaining or encouraging a healthy lifestyle and are unrelated to the diagnosis,
cure, mitigation, prevention, or treatment of a disease or condition from the definition of device in section 201(h) of the FD&C Act.
5 We have included examples of products below
that meet the definition of general wellness products to help illustrate the concepts in the
guidance.
A product's inclusion under the general wellness policy in this guidance does not establish
that it has been shown to be safe and/or effective for its intended use.
III. General Wellness Products
A general wellness product, for the purposes of this guidance, has (1) an intended use that
relates to maintaining or encouraging a general state of health or a healthy activity, or (2) an
intended use that relates 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,
this guidance does not apply.
The first category of general wellness intended uses involve claims about sustaining or
offering general improvement to functions associated with a general state of health that do
not make any reference to diseases or conditions. For the purposes of this 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 following are examples of this category of general wellness claims:
· Claims to promote or maintain a healthy weight, encourage healthy eating, or assist
with weight loss goals;
· Claims to promote relaxation or manage stress;
· Claims to increase, improve, or enhance the flow of qi “energy”;
· Claims to improve mental acuity, instruction following, concentration, problemsolving, multitasking, resource management, decision-making, logic, pattern
recognition, or eye-hand coordination;
Claims to enhance learning capacity;
· 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 (e.g., “fitness” or “activity”
trackers);
· Claims to promote sleep management, such 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, or enhance or
improve sexual performance;
· Claims to improve general mobility or to assist individuals who are mobility impaired
in a recreational activity (e.g., sport wheelchairs, beach access wheelchairs); 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 following are examples of claims that do not fall into this category of general wellness
claims:
· 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 an anxiety disorder;
· A claim that a computer game will diagnose or treat autism;
· A claim that a product will treat muscle atrophy or erectile dysfunction; and
· A claim to restore a structure or function impaired due to a disease or condition, e.g.,
a claim that a prosthetic device enables amputees to walk.6
The second category of general wellness intended uses relate to sustaining or offering general
improvement to functions associated with a general state of health while making reference
to diseases or conditions. For the purposes of this guidance, this second category of general
wellness claims is comprised of two subcategories:
1) intended uses to promote, track, and/or encourage choice(s), which, as part of a
healthy lifestyle, may help to reduce the risk of certain chronic diseases or
conditions; and
2) intended uses to promote, track, and/or encourage choice(s) which, as part of a
healthy lifestyle, may help living well with certain chronic diseases or conditions.
Both subcategories of disease-related general wellness claims should only be based on
references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition. That is, the claim that the healthy lifestyle
choice(s) may play an important role in health outcomes should be generally accepted; such
associations are described in peer-reviewed scientific publications or official statements
made by healthcare professional organizations.7 Examples of chronic diseases for which a
healthy lifestyle is associated with risk reduction or help in living well with that disease
include heart disease, high blood pressure, and type 2 diabetes.
The following are examples of this category of disease-related general wellness claims:
· Software Product U coaches breathing techniques and relaxation skills, which, as part
of a healthy lifestyle, may help living well with migraine headaches.
· Software Product V tracks and records your sleep, work and exercise routine which,
as part of a healthy lifestyle, may help living well with anxiety.
· Product W promotes making healthy lifestyle choices such as getting enough sleep,
eating a balanced diet, and maintaining a healthy weight, which may help living well
with type 2 diabetes.
· Product X promotes physical activity, which, as part of a healthy lifestyle, may help
reduce the risk of high blood pressure.
· Software Product Y tracks your caloric intake and helps you manage a healthy eating
plan to maintain a healthy weight and balanced diet. Healthy weight and balanced diet
may help living well with high blood pressure and type 2 diabetes.
· Product Z tracks activity sleep patterns and promotes healthy sleep habits, which, as
part of a healthy lifestyle, may help reduce the risk for developing type 2 diabetes.
IV. Determining Risk for General Wellness Products
CDRH’s general wellness policy applies only to general wellness products that are low risk.8
If the answer to any of the following questions is YES, the product is not low risk and is not
covered by this guidance.
1) Is the product invasive9
?
2) Is the product implanted?
3) Does the product involve an intervention or technology that may pose a risk to the
safety of users and other persons if specific regulatory controls are not applied, such
as risks from lasers or radiation exposure?
In assessing whether a product is low risk for purposes of this guidance, FDA recommends
that you also consider whether CDRH actively regulates products of the same type as the product in question. For example, CDRH actively regulates external penile rigidity devices,
which are devices intended to create or maintain sufficient penile rigidity for sexual
intercourse, under 21 CFR 876.5020 as class II devices exempt from premarket notification
with special controls. The special controls for these devices address risks to health that are
associated with the use of these devices, including, without limitation, tissue injury, trauma
or infection.10 Therefore, these types of devices would not be considered low risk general
wellness products.
The following are examples of products that would not be considered “low risk” as described
in this guidance:
· Sunlamp products promoted for tanning purposes, due to risks to a user’s safety from
the ultraviolet radiation, including, without limitation, an increased risk of skin
cancer.11
· Implants promoted for improved self-image or enhanced sexual function. Implants
pose risks to users such as rupture or adverse reaction to implant materials and risks
associated with the implantation procedure.
· A laser product that claims to improve confidence in user’s appearance by
rejuvenating the skin. Although the claims of rejuvenating the skin and improving
confidence in user’s appearance are general wellness claims, laser technology
presents risks of skin and eye burns.
· A neurostimulation product that claims to improve memory, due to the risks to a
user’s safety from electrical stimulation.
· A product that claims to enhance a user’s athletic performance by providing
suggestions based on the results of relative lactic acid testing, when the product uses
venipuncture to obtain the blood samples needed for testing. Such a product is not
low risk because it is invasive (e.g., obtains blood samples by piercing the skin) and
also because the product involves an intervention that may pose a risk to the safety of
the user and other persons if specific regulatory controls are not applied (e.g.,
venipuncture may pose a risk of infection transmission).
V. Examples of General Wellness Products that Are Not
Medical Devices and Examples of General Wellness
Products that Are Medical Devices for which FDA Does
Not Intend to Enforce Requirements
Illustrative Example 1: A software function plays music to “soothe and relax” an individual
and to “manage stress.” Such a software function is not a device function.
This software function has claims that relate only to relaxation or stress management,
not to any disease or medical condition, and thus are general wellness claims. In
addition, the technology to play music does not pose a risk to the safety of users and
other persons if specific regulatory controls are not applied. Therefore, this product
meets both factors for a low risk general wellness product.
Illustrative Example 2: A software function that solely monitors and records daily energy
expenditure and cardiovascular workout activities to “allow awareness of one’s exercise
activities to improve or maintain good cardiovascular health.” Such a software function is not
a device function.
This software function has a claim that relates to a specific organ only in the context
of general health and does not refer to a disease or medical condition. In addition,
although the monitoring or recording of exercise activities present risks (such as
inaccuracy), when made in the absence of disease or medical condition claims, the
technology does not pose a risk to the safety of users and other persons if specific
regulatory controls are not applied. Therefore, this product meets both factors for a
low risk general wellness product.
Illustrative Example 3: A software function monitors and records food consumption to
“manage dietary activity for weight management and alert the user, healthcare provider, or
family member of unhealthy dietary activity.” Such a software function is not a device
function.
This software function has a claim that relates to dietary choices and weight
management, and thus is a general wellness claim. In addition, the technology for
monitoring or recording food consumption does not pose a risk to the safety of users
and other persons if specific regulatory controls are not applied. Therefore, this
product meets both factors for a low risk general wellness product.
Illustrative Example 4: A software function that reminds users to keep exposed skin out of
direct sunlight when the UV index is high, which, as part of a healthy lifestyle, may help
reduce the risk of skin cancer.
This claim relates to tracking preventive measures which, as part of a healthy
lifestyle, may help reduce the risk of a medical condition. The claim is for a healthy
lifestyle choice and it is generally accepted that the choice may play an important role
in health outcomes. Thus, it is a general wellness claim. In addition, the technology
reminding users to keep exposed skin out of direct sunlight does not pose a risk to the
safety of users and other persons if specific regulatory controls are not applied.
Therefore, this product meets both factors for a low risk general wellness product.
Illustrative Example 5: A portable product that is intended to monitor the pulse rate of users
during exercise and hiking.
This claim relates only to exercise and hiking and does not refer to a disease or
medical condition. Thus, it is a general wellness claim. In addition, the technology for
monitoring pulse rate does not pose a risk to the safety of users and other persons if
specific regulatory controls are not applied. Therefore, this product meets both factors
for a low risk general wellness product.
Illustrative Example 6: A product is intended to mechanically exfoliate the face, hands and
feet to make the skin smoother and softer. The product cannot be used in a manner that
penetrates or pierces the skin.
This claim relates to self-esteem and does not refer to a specific disease or medical
condition, and thus is a general wellness claim. In addition, the product is noninvasive
as it does not penetrate the stratum corneum and the technology for exfoliating the
face does not pose a risk to the safety of users and other persons if specific regulatory
controls are not applied. Therefore, this product meets both factors for a low risk
general wellness product.
Note: However, if the product is intended to exfoliate the skin in order to enhance the
delivery of a topically applied product containing one or more active pharmaceutical
ingredients through the stratum corneum, the product would be invasive. Therefore,
the product would not be a low risk general wellness product.
VI. Determining whether General Wellness Products are
within Scope of the Guidance
The following questions reflect the framework described in this guidance to determine
whether general wellness products are within the scope of the guidance. Please note that
these questions are intended to be addressed in the context of the full text of the guidance.
A1. Does the product have an intended use that relates to maintaining or encouraging
a general state of health or a healthy activity?
Does the product only involve claims about sustaining or offering general improvement
to functions associated with a general state of health that do not make any reference to
diseases or conditions? Claims in this category include: weight management, physical
fitness, relaxation or stress management, mental acuity, self-esteem, sleep management,
or sexual function.
A2. Does the product have an intended use that relates the role of healthy lifestyle with
helping to reduce the risk or impact of certain chronic diseases or conditions? (In
answering this question, the following two questions must be considered together.)
a) Does the product have an intended use that relates to sustaining or offering general
improvement to functions associated with a general state of health while making
reference to 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?
AND
b) Is the relation between healthy lifestyle and disease specifically expressed as “may
help to reduce the risk of,” or “may help living well with,” a chronic disease or
condition?
A3. Is the product low risk?
Is the product not invasive, and not implanted, and does not involve a technology that
may pose a risk to the safety of users or other persons if specific regulatory controls are
not applied, such as risks from lasers or radiation exposure? In answering this question,
consider whether CDRH actively regulates products of the same type as the product in
question.
YES à Go to A3. Both questions A2(a) and A2(b) must be answered “Yes” in
order to proceed to question A3.
NO à Product is NOT a low risk general wellness product, and is outside the
scope of this guidance.
YES à The product is likely a general wellness product within the scope of
this guidance, but the factors and examples in the guidance should
be reviewed to confirm the status of the product.
NO à Product is NOT a low risk general wellness product, and is outside the
scope of this guidance
