Take a look at the wrist of many individuals today and you will likely see a device monitoring physical activity. Whether it be a stand-alone device or one in the form of a watch which also facilitates telephone and text conversations, the business of personal wellness is growing. In 2014, Price Waterhouse estimated that over $200 million had been invested in wearable start-up ventures. Market research conducted by Business Wire indicates that the industry will grow to $40 billion between 2016-2030. Until the most recent guidance by FDA was released on July 29, 2016, new entries into the market were evaluated on a case-by-case basis to determine if the product met the definition of a medical device and if so, what type of approval or market clearance would be required. This was a resource-intensive exercise for both industry and the Agency.
The new Guidance sets out to define which general wellness products, wearable, software, hand-held or otherwise would be subject to regulation as a medical device. To be considered a general wellness product it must 1) be intended for general wellness use and, 2) not pose a harm to the user or other persons. General wellness products may be purchased routinely thru retail outlets and include software, exercise equipment, audio recordings, and video games.
Devices which do not make disease claims but promote a healthy lifestyle include items such as software for managing caloric intake, monitors of exercise output and audio tapes for relaxation. Devices which make disease claims may only do so for those relationships between the device function and the disease state which are readily understood and widely accepted. These would include products monitoring exercise, diet and sleep as a means of promoting wellness in individuals with Type II diabetes.
Devices falling under the scope of this Guidance may not pose a risk to the user or other persons. All devices which are invasive, implantable, or pose a risk to others due to the nature of the device (specifically, lasers and radiation emitting devices) are not considered low risk and are not covered under the Guidance.
The Guidance provides examples to help industry make the determination of a general wellness device and a flow chart to aid in decision making. A good rule of thumb is, if the device you intend to market is already under a 510(k) with special controls, it is not considered low risk and therefore, would not fall under the scope of this Guidance.
A word of caution for those entering the general wellness arena: be sure you do your research and be sure you document your decisions. While you may follow the Guidance and understand there is no 510(k) for a similar device on the market, the onus is upon the device owner to demonstrate the device falls under the definitions of general wellness. This documentation should include any research performed, an assessment of the device meeting the definition of general wellness, including any marketing and labeling, intended use and risk profile. The decision tree should be well documented and available for review by FDA. This proactive approach may help avoid a regulatory action for an unapproved new device should it be called into question.
The complete Guidance document can be seen (here).