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# Design Medical Devices for Interoperability: CDRH
- URL: https://www.fdaweb.com/design-medical-devices-for-interoperability-cdrh/
- Published: 2017-11-02T12:00:00.000Z
- Updated: 2026-09-14T22:59:40.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5140041

During a recent FDA [Webinar](https://www.fda.gov/MedicalDevices/NewsEvents/WorkshopsConferences/ucm574592.htm?ref=fdaweb.com) on an agency final guidance on design considerations and premarket submission requirements for interoperable medical devices, CDRH senior science health advisor **Heather Agler** said the agency suggests that companies design systems with interoperability as an objective. “Think about this upfront when you’re thinking about your device, conducting appropriate verification, validation, and risk management activity,” she urged. “And specifying the relevant functional performance and interface characteristics in a user available manner such as labeling.”

Agler said the guidance’s scope provides manufacturers with the design considerations when developing interoperable medical devices.

The document defines interoperable devices as those that have the ability to change and use information through an electronic interface with another medical or non-medical product, system, or device, she said. And it defines an electronic interface as the medium by which systems interact and/or communicate with each other, allowing the exchange of information between systems.