FDA Makes Recommendations For "Low Risk" Health Technologies
By Megan Williams, contributing writer
The wearables market has been largely unregulated up to this point, but IT solutions providers in the mHealth niche will want to keep an eye on some recent moves made by the Food and Drug Administration (FDA).
New Guidance Document
The FDA has issued guidance around products considered “low risk,” and that promote a healthy lifestyle or general wellness.
Many wearables and mHealth apps will fall under those classifications. It is worth noting that the document has only been issued as a recommendation, and no regulatory or statutory requirements have yet been introduced. The draft provides language as to what qualifies as a “general wellness claim,” and includes claims like:
- Promoting or maintaining a health weight
- Promoting physical fitness through logs, tracking, or trend exercise activity
- Promoting sleep management
It further describes a “general wellness” product: “A general wellness product, for the purposes of this guidance, has (1) an intended use that relates to a maintaining or encouraging a general state of health or a healthy activity, or (2) an intended use claim that associates the role of healthy lifestyle with helping to reduce the risk or impact of certain chronic diseases or conditions and where it is well understood and accepted that healthy lifestyle choices may play an important role in health outcomes for the disease or condition.”
Impact On mHealth
The document also contains examples specifically addressing the question of “low risk” mobile apps and wearables. The first example focuses on a mobile app that uses music as a relaxation and stress-management aid:
“These claims relate only to relaxation or stress management, not to any disease or medical condition, and thus are general wellness claims. In addition, the technology to play music does not present inherent risks to a user’s safety. Therefore, this product meets both factors for a low risk general wellness product.”
The fourth example focuses on a wearable solution that monitors the pulse rate during exercise and hiking:
“This claim relates only to exercise and hiking and does not refer to a disease or medical condition. Thus, it is a general wellness claim. In addition, the technology for monitoring poses a low risk to the user’s safety. Therefore, this product meets both factors for a low risk general wellness product.”
It also provides a decision algorithm for any IT solutions provider that may still question whether their app or wearable is addressed.
Looking for ways to help your clients build better healthcare apps? Get insight into best practices here.