Compliance Zen: Majority of Mobile Health Apps Class II Devices for FDA:
"FDA’s current draft guidance on mobile medical apps is woefully short of such practical specifics. And yet it’s these specifics that will get even the most forthright medical app developer in trouble with FDA-483s and Warning Letters. Warning Letters have been shown to reduce product sales by at least 8% the first year and for three years thereafter. For many of these developers, a Warning Letter might be the kiss of death and bring a painful chill to the innovation marketplace."
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