Health care app developers clash with FDA

04/17/2012 | Politico (Washington, D.C.)

Developers of smartphone applications are typically not accustomed to dealing with federal regulators, setting up a culture clash between the FDA and health care app developers. The agency does not intend to regulate general health and wellness apps, but developers of apps that claim it can diagnose or treat a medical condition must demonstrate the app's safety and efficacy under rules for marketing medical devices.

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Politico (Washington, D.C.)

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