The U.S. Food and Drug Administration (FDA) is taking steps to ease its regulatory oversight of low-risk consumer wellness devices and software.
Issued in early January, the FDA’s draft guidance, titled “General Wellness: Policy for Low-Risk Devices,” clarifies that the agency will no longer subject fitness wearables and other consumer wellness devices intended to support healthy lifestyles to the same level of scrutiny as medical devices.
At the same time, the guidance makes clear that marketing claims for wellness devices will still be subject to FDA scrutiny. Specifically, devices that market themselves as “medical grade” or claim use for diagnosis or treatment of health-related conditions will continue to be subject to strict reviews.
“We want to let companies know, with very clear guidance, that if their device or software is simply providing information, they can do that without FDA regulation,” noted FDA Commissioner Marty Makary in an interview on the Fox Business Network show “Varney & Company.”
However, according to Makary, “the only stipulation is if they make claims of something being medical grade…we don’t want people changing their medicines based on something that’s just a screening tool or an estimate of a physiological parameter.”
The draft guidance updating the agency’s policy on low-risk wellness devices is available at https://www.regulations.gov/document/FDA-2014-N-1039-0001. Comments on the draft guidance must be submitted by April 20th through the Regulations.gov website (reference Document ID FDA-2014-N1039-0001).
