Law360, New York (January 21, 2015, 6:05 PM EST) -- New guidances from the U.S. Food and Drug Administration ease regulatory hurdles for low-risk medical devices in important ways and bode well for looming decisions on how strictly to police next-generation health information technology, experts say.
The two guidances, which were unveiled Friday, apply to medical device accessories and "wellness" products that support healthy lifestyles. The documents explained how products in the respective categories will be evaluated to determine how much oversight is appropriate, and they joined a string of FDA actions over the past couple of years to ease oversight of nontraditional wares in the health IT space.
"They're both positive,"...
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