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# Interoperable Medical Device Design Guidance
- URL: https://www.fdaweb.com/interoperable-medical-device-design-guidance/
- Published: 2017-09-05T12:00:00.000Z
- Updated: 2026-09-14T22:46:36.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5139541

FDA has issued a guidance, *Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices*, highlighting considerations the agency believes should be included in the development and design of interoperable medical devices and providing recommendations for the content of premarket submissions and labeling for such devices. The [document](http://links.govdelivery.com/track?type=click&enid=ZWFzPTEmbWFpbGluZ2lkPTIwMTcwOTA1Ljc3NzA5NDcxJm1lc3NhZ2VpZD1NREItUFJELUJVTC0yMDE3MDkwNS43NzcwOTQ3MSZkYXRhYmFzZWlkPTEwMDEmc2VyaWFsPTE3NDQ2Mzc1JmVtYWlsaWQ9ZGF2aWRAZmRhd2ViLmNvbSZ1c2VyaWQ9ZGF2aWRAZmRhd2ViLmNvbSZmbD0mZXh0cmE9TXVsdGl2YXJpYXRlSWQ9JiYm&&&100&&&https://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM482649.pdf?source=govdelivery&utm%5Fmedium=email&utm%5Fsource=govdelivery) says that as electronic medical devices are increasingly connected to each other and to other technology, the ability of the 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 says.

Topics covered in the guidance are background, scope, definitions, design considerations for interoperable medical devices, and recommendations for content of pre-submissions.