2019 FDA Guidance - General Wellness: Policy for Low Risk Devices

Innolitics introduction 🔗

When you’re developing a product that may be a medical device, one of the first questions to ask is: Is it a medical device? Usually this is a straightforward question to answer. One exception is general wellness products. This FDA Guidance discusses general wellness devices. If your product is a general wellness device, you’ll want to be certain the FDA will agree. Manufacturers often get into trouble when they believe their product is a general-wellness product when it isn’t. If competitor’s products are medical devices (you can use our FDA Browser to find out), chances are yours will be too.

If you’d like help navigating this topic, we’d be happy to help develop a regulatory strategy for your product. We’re experts in the Software as a Medical Device (SaMD) space.

About this Transcript 🔗

This document is a transcript of an official FDA (or IMDRF) guidance document. We transcribe the official PDFs into HTML so that we can share links to particular sections of the guidance when communicating internally and with our clients. We do our best to be accurate and have a thorough review process, but occasionally mistakes slip through. If you notice a typo, please email a screenshot of it to Miljana Antic at mantic@innolitics.com so we can fix it.

Preamble 🔗

Document issued on September 27, 2019.

For questions about this document, contact the Division of Digital Health by e-mail at digitalhealth@fda.hhs.gov.

Contains non-binding guidance.

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, problem-solving, 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.

Response	Action
YES →	Go to A3.
NO →	Go to A2.

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.)

1. 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
2. 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?

Response	Action
YES →	Go to A3. Both questions A2(a) and A2(b) must be answered “Yes” in order to proceed to question A3.
NO →	Product is NOT a low risk general wellness product, and is outside the scope of this guidance.

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.

Response	Action
YES →	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 →	Product is NOT a low risk general wellness product, and is outside the scope of this guidance.

Footnotes 🔗