General wellness apps and devices won’t face tough FDA scrutiny, as long as they only promote general wellness and present a low risk to the safety of those who use them.
In final guidance on the tools, the Food and Drug Administration says the Center for Devices and Radiological Health “does not intend to examine low-risk general wellness products.” Those products include wearables, apps, video games and software programs.
Epstein Becker Green health attorney Brad Thompson, who had previously commented to FierceHealthIT on the draft guidance, said in an email the final version "strikes the right balance between regulation and innovation."
"Over the intervening year and a half, I have talked to a lot of developers of wearable technologies and associated mobile apps and have used the draft guidance as a roadmap for how to assess FDA jurisdiction. I have found it to be extremely practical," he added.
He also applauded the change of wording from "very low risk" in the draft to "low risk" in the final version, saying that most likely the FDA saw the former phrase as "setting the bar too high."
In outlining how to decipher if a tool is low-risk, the guidance says it cannot be invasive, cannot be implanted and cannot use technology that would pose a risk to patients if specific regulatory controls are not in place.
The guidance also notes there are two categories of general wellness products: those that aim to improve overall health but don’t make any references to specific diseases or conditions and those that do reference diseases or conditions.
Disease-related general wellness claims, the FDA goes on to say, “should only be based on references where it is well understood that healthy lifestyle choices may reduce the risk or impact of a chronic disease or medical condition."
Thompson noted that this is the "one fly in the ointment." The FDA says those references include either peer-reviewed literature or professional society guidelines as useful in managing the disease or condition.
"That strikes me as a little bit narrow, because, for example, one might use CDC guidelines as a basis. Ironically, governmental guidelines are not included in the evidence of generally recognized as useful," he said. "So I think they got a little bit too aggressive in trying to be too precise about what constitutes that general recognition."
The guidance is open for comment at any time, according to an announcement in the Federal Register.
The FDA isn’t the only government agency looking at how to regulate wellness devices and apps. Last week, the Office of the National Coordinator for Health IT addressed a lack of HIPAA oversight for the tools in a report to Congress.