FDA releases draft guidance – General Wellness: Policy for Low Risk Devices

Whether you watched the international consumer electronics show this year or not, it’s hard not to notice the plethora of devices used to monitor health and wellbeing. However, are these devices considered products from the perspective of the FDA and thus are subject to regulation? Well, it all comes down to what the product claims it can do. To help answer this question FDA released a draft guidance to define their current thinking on policy for low risk devices having to do with general wellness. As with all draft guidance’s, it is currently open for comment, details on how to submit comments are provided at the end of this update.

To begin with, for the purposes of the guidance document general wellness products are defined 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 very low risk to users’ safety.
General wellness products may include exercise equipment, audio recordings, video games, and software programs.

The first category of general wellness intended uses involve claims about sustaining or offering general improvement to conditions and 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.

Some examples of claims that do not fall into this category include:

• 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 anxiety;

CDRH’s general wellness policy does not extend to devices that present inherent risks to a user’s safety. Whether a device is low risk for purposes of this guidance is determined by whether or not the product:

1. is invasive;
2. involves an intervention or technology that may pose a risk to a user’s safety if device controls are not applied, such as risks from lasers, radiation exposure, or implants;
3. raises novel questions of usability; or
4. raises questions of biocompatibility.

For knowing more about other categories, the draft guidance can be found at: General Wellness: Policy for Low Risk Devices; Guidance for Industry and Food and Drug Administration Staff.

? Email us at info@mdiconsultants.com if you have further questions. Ref: General Wellness