FDA regulation of mobile health: a study in ambiguity

The signs are not good when FDA continues to delay on issuing its draft guidance on mHealth devices (now tagged for the close of FY 2013), yet sends a notice to India’s Biosense Technologies Pvt Ltd, developer of the uChek Urine analyzer app, that it immediately needs to seek 510(k) Class II clearance. Biosense claims Class I clearance; FDA claims that it has no record. Letters fly, yet the app remains in the iPhone AppStore. How can there be a crackdown on mobile health apps, as FierceMobileHealthcare’s Greg Slabodkin projects, when developers legitimately say there’s no rules of the road? Magic 8 Ball says: ‘In The Fog’.  Also Mobihealthnews.

Previously in TTA: FDA regulating medical apps–or not? The Hearings. If not FDA to regulate mHealth, then who? An ‘Office of mHealth’ a solution for FDA gridlock?

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