“The U.S. Food and Drug Administration has issued preliminary guidance that defines the agency’s criteria for determining when wearables which provide health tracking or advice, such as the forthcoming Apple Watch, could be classed as regulated medical devices,” Sam Oliver reports for AppleInsider.
“According to the draft — which is currently open for a 90-day public comment period — wearables will not be considered medical devices unless they make claims about fitness to treat specific diseases or conditions, or present inherent risks to consumers’ safety,” Oliver reports. “Among the claims that the FDA will allow under the umbrella of ‘general wellness’ are those related to weight management, physical fitness, relaxation or stress management, mental acuity, self-esteem, sleep management, or sexual function.”
Oliver reports, “Following the release of iOS 8 and its new Health app, the agency said when asked about the meetings that Apple ‘wants to make sure they are on the side of the FDA’ and that ‘the earlier FDA is involved and advising, the less likely that Apple would be caught by surprise later when they wish to release a new product, if that product must be regulated.'”
Read more in the full article here.
[Thanks to MacDailyNews Readers “Fred Mertz” and “Dan K.” for the heads up.]