FDA has issued the final guidance for general health and wellness devices
The FDA has issued its policy for health and wellness devices which are considered to be of low risk to provide clarity to the industry for wellness devices that are of low risk that promote healthy lifestyles, on the 29th of July 2016. Devices that are considered general wellness with low risk fall into the categories of fitness trackers, weight loss applications, sleep management products and exercise equipment.
The guidance from the FDA spells out that FDA does not need to oversee devices that are intended for general wellness and has a low risk to the safety of user and other person, in the course of using the device. The guidance for this classification of devices is that the product is to support and encourage Healthy Activity or reduce the impact of certain types of chronic diseases, where is it well known that physical activity may provide a better health outcome.
Definition of General Wellness Products
According to the document, there are 2 categories defined.
Category 1. general wellness is defined as intended use to maintain or encourage a general state of health or healthy activity.
Category 2 which relates to reduction of risk or impact of certain chronic diseases or conditions where healthy lifestyles may play an important part in the outcomes for the diseases or condition.
Category 1 : Maintain or Encourage General State of Health or Healthy Activity
Category 2 : Helps to reduce the risk or impact of certain Chronic Diseases or conditions where healthy lifestyle choices make an impact.
Devices that promote, track or encourage healthy choices that may help reduce the risk of certain chronic diseases or conditions
Devices that may help living well with certain chronic diseases or condition
How does the FDA determination of Low Risk ?
The FDA spells out the following 3 tests to help determine low risk. This definition makes it very clear to the industry that most digital health products today, would pass all 3 test.
If the product is invasive.
Does the product have to be implanted
Does the product requires intervention that may pose a risk to the users or other persons.
This definition makes it very clear to the industry that most digital health products today, would pass all 3 test.