The FDA recently published a guidance document regarding its intentions to regulate certain medical mobile applications to ensure their safety and efficacy. Only mobile apps which meet FDA’s medical device definition and which have the potential to harm patients if they malfunction will be placed under FDA regulations. Applications which are classified as medical devices but do not pose a significant risk to patients or those that are not medical devices will be excluded from regulations. How do you think this change will impact the use of medical mobile apps by both health care providers and patients?
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