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Medical Device Interoperability: Is the FDA’s Move for Draft Guide the Right One?

Shared by Radhika Narayanan | 7 47 0 | about 2 years ago

Medical Device Interoperability: Is the FDA’s Move for Draft Guide the Right One?

Medical Device Interoperability: Is the FDA’s Move for Draft Guide the Right One?
by Erica Garvin 03/21/2016 0 Comments

airstrip medical device interoperability

Now is not time to put the demands of medical device interoperability on developers. AirStrip’s Dr. Matthew Patterson explains.

Interoperability has become a hot-button issue in U.S healthcare. So much so, the FDA has recently unveiled draft guidance in the hopes of indoctrinating the medical device industry with the task of tackling it head on. But will applying pressure to the shoulders of the innovators be the answer to hurdling interoperability in healthcare?

The guidance calls on device manufacturers to design systems with interoperability as an objective in the pursuit of safety stating: “Increased use of interoperable medical devices has the potential to foster rapid innovation at lower cost. However, appropriate safety considerations, including system level safety considerations that are not taken into account in the device design can result in unforeseen safety and effectiveness issues for the device or for the system.”

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Categories FDA Interoperability & Integration Medtech & Devices

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