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

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


Date:
October 26, 2017
Time:
October 26, 2017

             

Webinar Materials

On September 5, 2017, the FDA released a final guidance outlining the Agency’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.

On Thursday, October 26, 2017, the FDA hosted 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.

Target Audience: Industry

If you have any questions, 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.