With its most recent draft guidance, the FDA is trying to make it easier for developers of wellness devices and applications to determine whether their products would be regulated by the FDA as medical devices. This latest guidance was formulated in response to requests from the health IT industry that the FDA develop categories of products that pose a low risk to consumers and thus would be unregulated.
Historically, the FDA has maintained the position that products intended to benefit an individual’s overall health and wellness would not be regulated as medical devices, as long as the products did not make claims about disease prevention, treatment, mitigation, or cure. And the draft guidance confirms that position.
The guidance defines general wellness products as those that:
- Are intended for only general wellness use, as defined in this guidance
- Present a very low risk to users’ safety
According to the FDA, “general wellness products may include exercise equipment, audio recordings, video games, software programs and other products that are commonly, though not exclusively, available from retail establishments (including online retailers and distributors that offer software to be directly downloaded), provided these two criteria are met.”
General wellness products won’t be regulated as long as they claim to sustain or offer general improvement to conditions and functions associated with a general state of health. However, if a product makes any claim about a certain disease or condition, it is no longer considered a low-risk general wellness product and is not covered by the guidance.
Not everyone is pleased with the guidance. Health IT Now, a coalition of patient groups, provider organizations, employers, and payers that supports incentives to deploy heath information technology to improve quality, outcomes, and patient safety and to lower costs, issued this press release in response.
As always, stakeholders have 90 days to respond to the draft guidance and send comments to the FDA.