FDA Steps up Oversight on Medical Apps

By Arlene Weintraub

When the U.S. Food & Drug Administration sent a warning letter to an Indian app developer in late May, tech entrepreneurs in this country took notice. The FDA warned Biosense Technologies Private Ltd. that its app—which is designed to work with a urine-testing kit—is actually a medical device, and therefore it must be cleared by the agency.

The large and growing community of app developers doesn’t expect this to be the last time the FDA weighs in on mobile apps marketed for health-related uses. “There are millions of medical apps out there. The industry is concerned,” says Gabriel Vorobiof, a Los Angeles cardiologist and co-founder of PadInMotion, a New York company developing mobile tools for hospital use. “It’s just not clear how far [the FDA] will go.”


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