FDA Presentation: Mobile Medical Apps, MDDS, General Wellness Apps, 2/15
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In this February 2015 presentation, the CDRH branch of the FDA provides additional clarity regarding their guidance documents for Mobile Medical Applications, General Wellness Applications, and Medical Device Data Systems.
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FDA Guidance: Mobile Medical Apps, 2/15
This February 2015 FDA guidance provides information about how the agency intends to apply its regulatory authority to software applications on mobile platforms.
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FDA Guidance: General Wellness: Policy for Low Risk Devices, 7/16
This July 2016 FDA Guidance is intended to provide clarity on the compliance polity for low risk products that promote a healthy lifestyle.
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FDA Presentation: General Wellness Guidance: Policy for Low Risk Devices, 9/16
September 2016 FDA CDRH presentation to provide clarity and examples of low risk medical devices for general wellness.
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