In a move meant as a warning shot for an entire industry, the FDA has sent a letter to the makers of the medical app uChek informing them of a pending investigation. The FDA has been watching the rapidly growing ecosystem of medical apps with dismay and caution. Clearly they are now beginning what could be a tsunami of investigations, fines, and closures.
The medical app community has steadily grown to now include 40,000, all of which are unregulated and offer varying degrees of medical advice and potential safety risks. Of particular interest to the FDA are apps that are used in clinical settings. Far from self-help or public curiosities, these clinical apps are used by professionals to give patients diagnoses and treatment recommendations.
Far from terrible news, many app developers welcome the investigation as it could remove much of the uncertainty around the rules and regulations pertaining to medical apps. With entire accelerators organized around developing medical apps, any kind of boundaries or guidelines will be welcome.
While the industry is eager to see the outcome, no doubt that uChek is less enthused about the letter. The app is used to read the results of urine-test strips and detect concentrations or absences of substances in a patient’s urine. In a public statement, UChek’s parent company stated “We intend to work very closely with the U.S. FDA over the coming months to ensure that we continue to deliver accurate, affordable and convenient diagnostics across the world.”
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