FDA Finalizes Guidance on Interoperable Devices

Posted 05 September 2017 By Zachary Brennan

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The US Food and Drug Administration (FDA) on Tuesday finalized guidance outlining recommendations on how medical devices should be able to securely interact with other devices and information systems.

The guidance, first drafted in January 2016, is meant to assist manufacturers and FDA staff in identifying considerations related to the ability of electronic medical devices to safely and effectively exchange information and use exchanged information from devices.

It also features help for companies designing and developing interoperable medical devices, and recommendations regarding information to include in device labels and premarket submissions.

"FDA’s first concern, of course, is safety. Errors and inadequate interoperability, such as differences in units of measure (e.g., pounds vs. kilograms) can occur in devices connected to a data exchange system. Our guidance recommends appropriate functional, performance, and interface requirements for devices with such interactions," Bakul Patel, associate director for digital health in FDA’s Center for Devices and Radiological Health, wrote Tuesday.

He further stressed the importance of transparency, recommending that designers and manufacturers provide information on a device’s performance and interface characteristics so that those using it with other devices and systems can be safe.

FDA said in Tuesday's Federal Register that it recognizes and anticipates that the agency and industry may need up to 60 days to perform activities to operationalize the policies within the guidance.

"If new information regarding device interoperability as outlined in this guidance is not included in a premarket submission received by FDA before or up to 60 days after the publication of this guidance, CDRH staff does not generally intend to request such information during the review of the submission. CDRH does, however, intend to review any such information if submitted," the agency said.

Final Guidance

Webinar - Design Considerations and Premarket Submission Recommendations for Interoperable Medical Devices Final Guidance - October 26, 2017

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Categories: Medical Devices, Regulatory strategy, Regulatory intelligence, Submission and registration, News, US, CDRH

Tags: interoperable medical devices, EHRs and devices

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