General Wellness: Policy for Low Risk Devices

Contains Nonbinding Recommendations

General Wellness:

Policy for Low Risk Devices

Guidance for Industry and

Food and Drug Administration Staff

Document issued on September 27, 2019.

Document originally issued on July 29, 2016.

For questions about this document, contact the Division of Digital Health by e-mail at

[email protected].

U.S. Department of Health and Human Services

Food and Drug Administration

Center for Devices and Radiological Health

Contains Nonbinding Recommendations

Preface

Public Comment

You may submit electronic comments and suggestions at any time for Agency consideration

to https://www.regulations.gov. Submit written comments to the Dockets Management Staff,

Food and Drug Administration, 5630 Fishers Lane, Room 1061, (HFA-305), Rockville, MD

20852.

Identify all comments with the docket number FDA-2014-N-1039. Comments may not be

acted upon by the Agency until the document is next revised or updated.

Additional Copies

Additional copies are available from the Internet. You may also send an e-mail request to

CDRH[email protected] to receive a copy of the guidance. Please use the document

number 1300013 and complete title of the guidance in the request.

Contains Nonbinding Recommendations

Table of Contents

I. Introduction ....................................................................................................................... 1

II. Policy on Low Risk General Wellness Products ............................................................... 2

III. General Wellness Products ................................................................................................ 3

IV. Determining Risk for General Wellness Products ............................................................ 5

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 ............................................................................................................... 6

VI. Determining whether General Wellness Products are within Scope of the Guidance ...... 8

Contains Nonbinding Recommendations

General Wellness:

Policy for Low Risk Devices

Guidance for Industry and

Food and Drug Administration Staff

This guidance represents the current thinking of the Food and Drug Administration (FDA or

Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or

the public. You can use an alternative approach if it satisfies the requirements of the applicable

statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office

responsible for this guidance as listed on the title page.

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).

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.

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 does not change or rescind any requirements of the Federal Food, Drug, and Cosmetic Act

(FD&C Act) or any applicable regulations. This guidance also does not preclude FDA from consulting with the

Consumer Product Safety Commission (CPSC) as to whether a general wellness product is a consumer product

under CPSC’s authority or a device. FDA may coordinate with other agencies and authorities, such as the

CPSC, to determine jurisdiction over products. If a product is a device under section 201(h) of the FD&C Act, it

is generally excluded from CPSC’s authority over “consumer products” under the Consumer Product Safety Act

(15 U.S.C. § 2052(a)(5)(ii)(H)). However, CPSC and FDA may both have jurisdiction over certain medical

devices under other statutory authorities the CPSC administers.

For determinations on combination products, contact the Office of Combination Products at

[email protected]. See 21 CFR 3.2(e) for the definition of a combination product.

Contains Nonbinding Recommendations

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 devices

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

programs

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

The term “device” is defined in 201(h) of the FD&C Act to include an “instrument, apparatus, implement,

machine, contrivance, implant, in vitro reagent, or other similar or related article, including any component,

part, or accessory, which is …intended for use in the diagnosis of disease or other conditions, or in the cure,

mitigation, treatment, or prevention of disease, in man … or intended to affect the structure or any function of

the body of man...” and “does not include software functions excluded pursuant to section 520(o) of the FD&C

Act.”

For more discussion regarding FDA’s regulatory approach towards certain device software functions and

mobile medical applications, see the FDA Guidance: Policy for Device Software Functions and Mobile Medical

Applications, available at https://www.fda.gov/regulatory-information/search-fda-guidance-documents/policy-

device-software-functions-and-mobile-medical-applications.

Contains Nonbinding Recommendations

device in section 201(h) of the FD&C Act.

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, problem-

solving, multitasking, resource management, decision-making, logic, pattern

recognition, or eye-hand coordination;

“Nothing in this subsection shall be construed as limiting the authority of the [FDA] to— (A) exercise

enforcement discretion as to any device subject to regulation under this Act . . .” (section 520(o)(4) of the

FD&C Act).

Contains Nonbinding Recommendations

· 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.

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

Products intended to restore a structure or function impaired due to a disease might be regulated by FDA as

devices. For example, an artificial limb prosthesis intended to provide disabled persons the ability to walk might

be regulated under 21 CFR 890.3420 or 21 CFR 890.3500.

Contains Nonbinding Recommendations

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.

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.

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 invasive

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

By organizations we mean associations and colleges such as American Medical Association (AMA),

American Heart Association (AHA), American Association of Clinical Endocrinologists (AACE), American

College of Rheumatology, etc.

Whether a device is classified as class I under section 513(a)(1) of the FD&C Act does not necessarily mean

that it is “low risk” for purposes of this guidance.

For purposes of this guidance, “invasive” means penetrates or pierces the skin or mucous membranes of the

body.

Contains Nonbinding Recommendations

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.

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.

· 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

See the FDA Guidance: Class II Special Controls Guidance Document: External Penile Rigidity Devices,

issued on December 28, 2004, available at https://www.fda.gov/regulatory-information/search-fda-guidance-

documents/class-ii-special-controls-guidance-document-external-penile-rigidity-devices-guidance-industry-and.

See Final Order reclassifying UV lamps intended to tan the skin from class I exempt from premarket

notification to class II (special controls): General and Plastic Surgery Devices: Reclassification of Ultraviolet

Lamps for Tanning, Henceforth To Be Known as Sunlamp Products and Ultraviolet Lamps Intended for Use in

Sunlamp Products, available at https://www.federalregister.gov/articles/2014/06/02/2014-12546/general-and-

plastic-surgery-devices-reclassification-of-ultraviolet-lamps-for-tanning-henceforth-to.

Contains Nonbinding Recommendations

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.

Contains Nonbinding Recommendations

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.

YES à

Go to A3.

NO à

Go to A2.

Contains Nonbinding Recommendations

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.