For devices that the agency views as low-risk and satisfying other criteria laid out in draft guidance, the new category will lift the burden of seeking FDA clearance and manufacturing products under agency quality rules. In addition, the FDA will even allow makers of the general wellness devices to offer certain disease-specific claims, as long as certain conditions are satisfied.
For device makers, the challenge will be sorting out those conditions so that their allowed wellness advertising and marketing claims don’t inadvertently cross into treatment claims, that are not allowed.
In addition, device makers will need to be sure that their apps and devices satisfy the agency definitions of low-risk, otherwise the FDA can decide their devices require clearance and will be subjected to traditional regulation.
REFERENCE: FDA News; 20 FEB 2015