The new article highlights the aspects related to the way the risk related to general wellness products should be determined. 

The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to general wellness products. The document provides an overview of the FDA policy for low-risk medical devices, together with clarifications regarding the existing regulatory framework and recommendations to be taken into consideration to ensure compliance thereto. Provisions of the guidance are non-binding in their legal nature, nor are intended to introduce new rules or impose new obligations, but rather to assist medical device manufacturers and other parties involved with interpreting and following the principles set forth by the respective legislation. The authority also mentions that an alternative approach could be applied, provided such an approach is in line with underlying regulations and has been agreed with the authority in advance. 


Determining the Risk

The document covers, inter alia, the aspects related to the determination of risk for general wellness products. Under the general rule, it is important to ensure the product subject to review is low risk. The criteria to be considered in this respect are the following:

  1. Whether the product is invasive;
  2. Whether the product is invasive;
  3. Whether the product involves 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. 

Should the answer to all the questions outlined hereinabove be “No”, the product should be considered low risk, otherwise the policy described in the guidance will not apply. The authority also mentions that it is also important to take into consideration the way the authority regulates similar products already placed on the market. 

The document also provides examples of products that are falling outside the scope of low-risk products. They include, inter alia, the following ones:

  • A laser product that claims to improve confidence in the user’s appearance by rejuvenating the skin.
  • 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. 

General Wellness Products and Medical Devices

The document further provides examples of general wellness products that are not medical devices, as well as the ones that are medical devices for which the authority does not intend to enforce requirements. 

The first example is the software that is intended to help user to relax and manage stress by playing music. In such a case, the software function in question is not intended to be used in the context of a specific disease or condition, furthermore, the technology to play music does not expose users to additional risks. Hence, both criteria for low-risk general wellness products are met. 

Another example describes a software function intended to monitor and record food consumption to manage dietary activity for weight management and alert the user, healthcare provider, or family member of unhealthy dietary activity”. Following the applicable legislation, such a function is not considered to be a medical device function, consequently, the said product would not be subject to regulation under the medical device framework. In such a case, both the criteria of a low-risk general wellness product are met – the claims made by the manufacturer for the product are general wellness claims, while the technology the product is based on does not expose patients to additional risks, and additional regulatory controls are not required. 

A similar approach should be applied to a portable product that provides the functionality of measuring and monitoring pulse rate during exercise and hiking. The information provided by such a product is not intended to be used in the course of the medical decision-making process, while the way the device operates does not result in additional risks to the patients they are exposed to. 

The document also provides an example of a product intended to mechanically exfoliate the face, hands, and feet to make the skin smoother and softer. The authority additionally emphasizes that such a product should not penetrate the skin. Provided the above mentioned condition is met, the product should be considered a low-risk general wellness product. 


Determining the Applicability of the Guidance 

The document also highlights the aspects related to determining whether general wellness products are within the scope of the present guidance. In particular, the authority outlines the questions to be assessed, namely:

  • 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 have an intended use that relates the role of a healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions? 
  • Is the product low-risk?

In summary, the present FDA guidance describes in detail the regulatory approach to be applied to the products intended for general wellness purposes. According to the guidance, the main factors to be taken into consideration when determining the regulatory nature of such products are the claims made by the manufacturer to functionality and intended use of the products, as well as the technology the product is based on and risks associated thereto. 



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