The US Food and Drug Administration has addressed health and fitness wearables in a draft guidance document — and it seems that the FDA will not be regulating any products that are intended for “general wellness” purposes. Only when products are considered to be medical devices (either through its purpose or its marketing) will they be regulated.
According to the document, “A general wellness product… 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.” In other words, any product that claims to reduce risk of obesity is fine, but the FDA will look at products that claim they can cure obesity more closely.
The FDA’s guidance received mixed feedback. Epstein Beck Green attorney Bradley Merrill Thompson told Health Data Management that he though the guidance was great. “No longer does the mere mention of a disease in promotional materials mean that FDA may regulate it,” he said.
Meanwhile, the document got a negative reaction from Joel White, executive director at Health IT Now. He said he was “disappointed to see the release of FDA guidance attempting to define the regulatory parameters for health IT, not because we disagree with the policy, but because it continues FDA’s reach into new technologies at the same time Congress is working on changes to the FDA’s authority in this area.”
The FDA’s draft guidance document will receive input from stakeholders until April 20th. The FDA will begin working on the final version of the document after that time.