FDA Shows Deft Touch With 1st Mobile App Enforcement
By Jeff Overley (May 22, 2013, 7:27 PM EDT) -- The U.S. Food and Drug Administration's Tuesday move to rein in a developer of iPhone urinalysis software marked a perfectly balanced foray into stronger oversight of the fledgling mobile medical apps industry, experts say, addressing frustration among app makers that already work closely with regulators while taking care not to scare off potential innovators.
Experts had complained for months that India-based Biosense Technologies Pvt. Ltd.'s uChek app, which is being sold on Apple Inc.'s App Store to screen for diabetes and urinary tract infections, was clearly a medical device and had improperly failed to seek the FDA's blessing before going to...
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