FDA just released new policy related to Low-Risk devices: General Wellness: Policy for Low Risk Devices | FDA
First of all what is Low risk general wellness device?
The FDA defines general wellness products as products that meet two criteria:
1. they are intended only for general wellness use, and
2. they present a low risk to the safety of users and others
So, in practice, general wellness use refers to supporting overall health and well-being such as promoting exercise, relaxation, sleep, or stress awareness without diagnosing, treating, or preventing any disease.
The key difference between a regulated medical device and a non-regulated general wellness product lies in the intended use and claims. If a product makes medical claims related to disease or clinical conditions, it is considered a medical device and falls under regulatory oversight. If it only supports general well-being and presents low risk, it may qualify as a general wellness product and is not actively regulated by the FDA.
The FDA further breaks general wellness products into two types based on how the intended use is described.
- The first category includes products that support or improve general health functions without mentioning any diseases or medical conditions at all. These are the most straightforward general wellness products and focus on things like fitness, sleep, relaxation, or stress management.
- The second category allows limited references to diseases or conditions but only in the context of healthy lifestyle choices. These products may encourage or track behaviors that help reduce the risk of certain chronic conditions or support living well with them. The important thing is that they do not diagnose, treat, or manage the disease itself. In both cases, the focus remains on general wellness, not medical intervention.
What does it mean from the regulatory point of view?
When properly positioned, general wellness products are not regulated as medical devices. This allows for lighter regulatory requirements and faster market entry. In practice, this means that FDA clearance or approval is not required and manufacturers are not expected to comply with medical device regulations such as quality system requirements, clinical evaluation, or post-market surveillance.
However, this does not mean no responsibility. Manufacturers must still ensure that the product is safe, that marketing claims are truthful, and that the product remains consistent with its stated general wellness intended use. Poorly defined claims or feature creep toward medical functionality can quickly shift a product into medical device territory and lead to significantly higher regulatory burden, longer timelines, and more compliance risk. Crossing that line rarely happens intentionally but it almost always comes with more problems.
So what has been changed?
The FDA has clarified that some products using non-invasive sensing technologies, such as optical sensors, may still qualify as general wellness products even if they estimate or show physiological parameters like heart rate variability (HRV), oxygen saturation (Spo2), or blood pressure.
This is possible only when the outputs are intended only for wellness purposes. In practice, this means the product must remain non-invasive and not implanted and avoid any medical indication. It must not be used to diagnose, treat, prevent, or manage disease, nor position itself as a substitute for an FDA-authorized medical device. Equally important, the product must not guide clinical decisions or medical actions. Outputs should remain informational and wellness-oriented, not prescriptive. If the product presents values that resemble clinically used measurements, those values must be appropriately validated to reflect what they claim to represent.