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FDA Releases Guidance on Interoperable Devices

Sept. 14, 2017

The FDA unveiled final recommendations for how medical devices should be designed to interact with other devices and IT systems.  

The agency wants to encourage developers to consider interoperability issues, according Bakul Patel, CDRH’s associate director for digital health. The agency also is encouraging transparency among designers and manufacturers to minimize the risk associated with misuse of interoperable devices.

Failure to provide the information to the user may lead to an inappropriate use of the device interface in a way that can lead to device malfunction, and “may lead to patient injury and even death,” Patel said, in a Sept. 6 blog.

The guidance includes recommendations for labeling and premarket submissions.

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