The signs are not good when FDA continues to delay on issuing its draft guidance on mHealth devices (now tagged for the close of FY 2013), yet sends a notice to India’s Biosense Technologies Pvt Ltd, developer of the uChek Urine analyzer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?