Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff

Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices - Guidance for Industry and Food and Drug Administration Staff

Today, the FDA released the final guidance document "Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices." This final guidance outlines FDA’s recommendations for developing safe and effective devices that exchange and use patient information electronically.

The final guidance is intended to promote the development and availability of these devices by:

1. assisting industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange information and use exchanged information;
2. highlighting considerations for the design and development of interoperable medical devices; and
3. providing recommendations for the content of premarket submissions and labeling for such medical devices.

It is important to note that the recommendations in the final guidance focus on the information and content exchanged over electronic connections such as USB (Universal Serial Bus) and wireless, but does not focus on aspects of physical compatibility (i.e. physical connectors). Additionally, this final guidance will have a 60 day transition period to allow the FDA and industry to perform activities to address recommendations in the guidance.

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.

Thank you,

Food and Drug Administration
Center for Devices and Radiological Health