FDA released the final guidance document “Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.”

As electronic medical devices are increasingly connected to each other and to other technology, the ability of these connected systems to safely and effectively exchange and use the information that has been exchanged becomes increasingly important. Advancing the ability of medical devices to exchange and use information safely and effectively with other medical devices as well as other technology offers the potential to increase efficiency in patient care. FDA intends to promote the development and availability of safe and effective interoperable medical devices.

In this guidance FDA refer to interoperability as the ability of two or more products, technologies or systems to exchange information and to use the information that has been exchanged. In this context, exchange of information includes transmission, reception or both, regardless of the means or protocol by which the exchange happens. Device design elements that factor in interoperability considerations may improve data portability and patient safety. This guidance is intended to highlight the following items that medical device manufacturers should consider to provide a reasonable assurance of safety and effectiveness of their interoperable medical devices:

1. designing systems with interoperability as an objective;
2. conducting appropriate verification, validation and risk management activities;
3. specifying the relevant functional, performance, and interface characteristics in a user available manner such as labeling

This guidance provides manufacturers with design considerations when developing interoperable medical devices, and recommendations regarding information to include in premarket submissions and device labeling.

 

WEBINAR: On Thursday, October 26, 2017, the FDA will host a webinar for industry to discuss and answer questions about this final guidance. FDA employees are welcome to participate in this webinar and may join in listen-only mode. No registration is required.

• Date: Thursday, October 26, 2017
• Time: 1:00 – 2:30 PM EST (To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar)
• To hear the presentation and ask questions: Dial: 800-369-3128, International Callers Dial: 1-312-470-7334; Conference Number: PWXW5373095; Passcode: 2366523
• To view the slide presentation during the webinar: https://www.mymeetings.com/nc/join.php?i=PWXW5373095&p=2366523&t=c
• Following the webinar, a transcript, audio recording, and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.

To ensure you are connected, please dial-in 15 minutes prior to the start of the webinar.

Following the webinar, a transcript, recording and slides will be available at: http://www.fda.gov/CDRHWebinar. The slide presentation will also be available at this site on the morning of the webinar.

If you have any questions regarding this guidance document, please contact CDRH’s Division of Industry and Consumer Education (DICE) at DICE@fda.hhs.gov, or via phone at 1-800-638-2041, or 301-796-7100. For more information about the guidance please visit Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices.

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