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# Guidance on Interoperable Medical Devices
- URL: https://www.fdaweb.com/guidance-on-interoperable-medical-devices-2/
- Published: 2016-01-26T12:00:00.000Z
- Updated: 2026-09-15T02:30:38.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5134568

*Federal Register* Notice: FDA is making available a draft guidance entitled *Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices*. The agency aims to assist industry and FDA staff in identifying specific considerations related to the ability of electronic medical devices to safely and effectively exchange and use exchanged information. This document highlights considerations that should be included in developing and designing interoperable medical devices and provides recommendations for the content of premarket submissions and labeling for such devices. To download this guidance, click [here](http://www.fda.gov/ucm/groups/fdagov-public/@fdagov-meddev-gen/documents/document/ucm482649.pdf?ref=fdaweb.com). To view this notice, click [here.](https://www.gpo.gov/fdsys/pkg/FR-2016-01-26/pdf/2016-01471.pdf?ref=fdaweb.com)