Understanding FDA Guidance On Connected Medical Devices

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In the coming years, we expect to see an explosion in the number of interoperable medical devices. These are connected medical devices that have the ability to connect to different technologies and devices, even from other manufacturers. The U.S. Food and Drug Administration also recognizes the growing importance of these connected devices and issued final guidance on Sept. 6, 2017, relating to their safety.

Interoperable medical devices can provide incredibly valuable data to health care providers and patients. Health information that may have taken several doctors’ visits to gather could literally be at a patient’s fingertips with a tap on their smartphone.

Originally published in Law360 on October 16, 2017.

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DISCLAIMER: Because of the generality of this update, the information provided herein may not be applicable in all situations and should not be acted upon without specific legal advice based on particular situations.

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