Is it a General Wellness Product or a Medical Device?

Background 🔗

The 21st Century Cures Act removed FDA’s regulatory oversite of certain types of general wellness products. Developers and inventors of these devices can now distribute them without the regulatory burdens (i.e., design controls, premarket review, establishment registration, device listing, ongoing facility inspections) associated with medical devices. While this revision is a great opportunity for industry, it is also a cause of confusion and ambiguity. What products will the FDA consider to be general wellness devices? It’s an important question! We’ve seen the FDA crush business ventures when they reclassify a general wellness device as a medical device. In this article, we will help you answer this question for your device.

In an attempt to clarify their position, FDA released a guidance titled “General Wellness: Policy for Low Risk Devices”. The guidance offers the following definition of a general wellness product:

Products that meet the following two factors:

1. Are intended for only general wellness use,
2. Present a low risk to the safety of users and other persons.

What exactly is meant by “general wellness”? And what is considered “low risk”? We’ll consider both criteria in detail below, along with examples, but first it is important to understand FDA’s definition of a medical device:

An instrument, apparatus, implement, machine, contrivance, implant, in vitro reagent, or other similar or related article, including a component part or accessory which is:

• Recognized in the official National Formulary, or the United States Pharmacopoeia, or any supplement to them,
• Intended for use in the diagnosis of disease or other conditions, or in the cure, mitigation, treatment, or prevention of disease in man or other animals, or
• Intended to affect the structure or any function of the body of man or other animals,
• And does not achieve its primary intended purposes through chemical action within or on the body of man or other animals and which is not dependent upon being metabolized for the achievement of its primary intended purposes.

The following types of software functionality are explicitly excluded:

• Administrative support of a health care facility,
• Maintaining or encouraging a healthy lifestyle unrelated to the diagnosis, cure, mitigation, prevention, or treatment of a disease or condition,
• Serve as electronic patient records; or
• Transferring, storing, converting formats, or displaying test or other device data, results or findings but not intended to interpret or analyze them.

Note that it the intended use and indications for use, in addition to functionality, that determines whether your product is a medical device. You must know your product’s intended use and which marketing claims you need to make to be able to sell your device. Each aspect of the medical device definition presented above should be carefully considered. If your product meets any of them, it cannot be a general wellness product and you’ll have to meet the FDA’s regulatory requirements to sell in the U.S.

We can now return to the two criteria, general wellness and low risk, that your device must meet to be considered a general wellness product. Let’s explore both criteria in more depth.

Criterion 1 🔗

The product is intended only for general wellness use.

To meet this criterion, the product would be expected to provide functionality that maintains or encourages a general state of health or a healthy activity. FDA’s general wellness product guidance does allow for certain types of intended uses which in combination with a healthy lifestyle may help to reduce the risk or impact of certain chronic diseases or conditions where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.

The FDA guidance offers information related to general wellness intended uses and marketing claims for products which do not refer to chronic diseases or conditions as well as information related to general wellness intended uses and marketing claims for products which include references to chronic diseases or conditions.

Intended Use Examples 🔗

General wellness product without reference to a chronic disease or condition:

• Product X is intended to track dietary intake and provide information related to optimizing an individual’s weight management program.
• Product Y is intended to provide exercises and information to optimize mental acuity.

General wellness product with reference to a chronic disease or condition:

• Product A is intended to provide nutritional and exercise guidance which as part of a healthy lifestyle may help reduce the risk of high blood pressure.
• Product B is intended to record sleep patterns and provide exercise routines which, as part of a healthy lifestyle, may help living well with anxiety.

Marketing Claim Examples 🔗

General wellness product without reference to a chronic disease or condition:

• Product X promotes a healthy weight, encourages healthy eating, and assists with weight loss goals.
• Product Y improves mental acuity, instruction following, concentration, problem solving, multitasking, resource management and decision-making.

General wellness product with reference to a chronic disease or condition:

• Product A offers advanced, personalized metrics which promotes physical activity, which, as part of a healthy lifestyle, may help reduce the risk of high blood pressure.
• Product B provides an interactive, personalized program which tracks and records your sleep and exercise routines which, as part of a healthy lifestyle, may help living well with anxiety.

The guidance also provides examples of marketing claims which are not consistent with general wellness products. These include:

• Product C diagnoses and treats eating disorders, such as anorexia and bulimia.
• Product D helps treat Generalized Anxiety Disorder anxiety Disorder (GAD).
• Product E diagnoses and treats Autism.

As you can see, careful consideration must be taken in determining the intended use and marketing claims for a general wellness product as it may not be clear where the line is drawn between acceptable and unacceptable intended uses and marketing claims.

Criterion 2 🔗

The product presents a low risk to the safety of users and other persons

The concept of low risk can only be fully understood if one is familiar with FDA’s thinking on the topic of risk. As one of FDA’s core tenets is to protect public health, the estimation of the potential risk that a product carries is at the top of list for employing regulatory enforcement through general and special controls.

Risk assessment is the responsibility of the manufacturer. This carries the assumption that the manufacturer understands the way the device operates and will foreseeably be used. Medical device manufacturers and FDA lean heavily on an international standard titled ‘ISO 14971-Application of risk management to medical devices’. The 14971 standard specifies terminology, principles, and a process for risk management of medical devices, including software as a medical device. Estimation of risk can prove to be somewhat challenging for those new to FDA regulatory oversite. The determination that a product is considered low risk also presents a challenge. The first step in determining if a product is ‘low-risk’ is to perform a risk assessment. This activity is optimally performed by a team which includes the developers (software, firmware, mechanical, electrical as applicable), management, and marketing staff as this provides a 360-degree view of how the product operates, how it is intended to be used and the claims that are necessary to fulfill sales objectives. The risk assessment is generally performed using the following steps:

• Identify the product’s intended use
• Identify the various aspects of the product’s design (i.e., software/firmware, electrical, mechanical)
• Identify the product’s requirements (i.e., Customer requirements, engineering requirements, information to user (instructions))

Once these items have been determined, a table is typically created which lists the product requirements. The team then considers if there are any potential hazards which are related to the requirements. This includes:

• Consider the technology (software/firmware, electrical, mechanical)
• Consider how the product is intended to be used
• Consider any ‘foreseeable’ ways the product may be used outside it intended use

When potential risks (aka hazards) are identified, they are:

• Given a severity of harm rating
• Given an estimation of how likely it is that the hazard may occur over the lifetime of the device (probability of harm)

FDA accepts several methods to categorize severity of harm from healthcare products. One method is to categorize severity into five levels. The five levels of harm are catastrophic, critical, serious, minor, and, negligible harm:

• Catastrophic harm- Results in patient death
• Critical harm- Results in permanent impairment or life-threatening injury
• Serious harm- Results in injury or impairment requiring additional professional medical intervention. Compromised security of sensitive data
• Minor harm- Results in temporary injury or impairment not requiring additional professional medical intervention. Compromised security of non-sensitive data
• Negligible harm- Inconvenience or temporary discomfort. No or negligible risk to patient

The next step in the process is to determine the probability that a harm will occur. An example of a semi-quantitative method is shown below.

• Frequent- 1 in 100 (Definite chance of occurring)
• Probable- 1 in 1,000 (Very high chance of occurring)
• Occasional- 1 in 10,000 (Moderate chance of occurring)
• Remote- 1 in 100,000 (Slight chance of occurring)
• Improbable- Less than 1 in 1,000,000 (Very little or no chance of occurring)

The final step in the risk assessment process is to combine the severity of harm and the probability of occurrence of each identified hazard. This is typically done using a matrix where the severity and occurrence for each hazard meet. An example of is shown below.

5	Frequent	Low	Medium	High	High	High
4	Probable	Low	Medium	Medium	High	High
3	Occasional	Low	Low	Medium	High	High
2	Remote	Low	Low	Medium	Medium	High
1	Improbable	Low	Low	Medium	Medium	Medium
		Negligible	Minor	Serious	Critical	Catastrophic
		1	2	3	4	5

The outcome of the risk assessment will provide information for each identified hazard. If any of the risks are higher than ‘Low’ the product cannot be considered low-risk.

Summary of Actions 🔗

To determine whether your device is a general wellness product, we suggest performing the following actions:

1. Create an intended use statement for the product.

2. Create proposed marketing claims which are necessary for the product to be viable. The claims should be consistent with the intended use statement.

3. Consider each point of FDA’s medical device definition against the intended use statement and marketing claims. If the product meets any of the elements of the medical device definition it cannot be considered a low-risk general wellness product.

4. Perform a risk assessment. If the determination of risk acceptability is anything other than ‘Low’, the product cannot be considered a low-risk general wellness product

5. Review FDA’s “General Wellness Policy for Low-Risk Devices” guidance document. There are a series of questions which help in the process of determining if the product meets the criteria for a low-risk general wellness product.

If questions remain, come talk to us! We have expertise with FDA regulatory requirements. It’s important to classify your device correctly. If you believe your device is a General Wellness device, and FDA disagrees, your product may be immediately removed from the market or you may be issued ‘warning letters’ or other enforcement activities.