Medical Device Interoperability: Questions to Ask

By the Connected Diagnostics Evidence Team

What Does Medical Device Interoperability Mean?

Medical device interoperability is the ability of a connected medical device to safely, securely, and effectively exchange and use information with other devices, apps, or systems. That exchange can include displaying, storing, interpreting, analyzing, or letting one device automatically act on data from another, according to the FDA.

If a device connects to an app, a health record system, or another piece of equipment, interoperability is what determines whether that connection works as intended—and what happens if it does not.

Why Does Interoperability Matter for Connected Devices?

The FDA has said that as electronic medical devices become more connected, the ability of those systems to safely and effectively exchange information becomes critical. Interoperable devices can improve patient care, reduce errors and adverse events, encourage innovation, and support more diverse research datasets.

The same agency has also noted that cybersecurity concerns rise along with increasing device interoperability. Connection and openness are not free—they come with a security tradeoff worth understanding before you rely on a connected system.

What Interoperability Standards Does the FDA Recognize?

The FDA recognizes a specific set of voluntary technical standards manufacturers can use to help devices from different companies work together. Recognition began in 2013 with an initial standards set, and the FDA continues to add to it. Recognized standards include:

• ANSI/AAMI 2700-1 (2019) — essential safety requirements for equipment in a patient-centric integrated clinical environment
• AAMI/ANSI/UL 2800 series (2022) — medical device interoperability, including risk concerns and interoperable-item development and integration life cycles
• ISO/IEEE 11073 series — device communication standards for point-of-care devices and personal health devices
• DICOM (NEMA PS 3.1–3.20) — communication and management of medical imaging information and related data

A standard being FDA-recognized is not the same as a specific product being approved or designed to deliver to work with every other device. Recognition means the standard is available and encouraged—not that any two labeled-compatible devices will interoperate perfectly in every setting.

What Does the FDA’s Interoperability Guidance Actually Cover?

In September 2017, the FDA issued a final guidance document, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices (docket FDA-2015-D-4852), through its Center for Devices and Radiological Health. It helps manufacturers identify design considerations for interoperable devices and outlines what the agency recommends including in premarket submissions and product labeling.

This is manufacturer- and reviewer-facing guidance. It does not itself certify or commitment that any specific device on the market has fully implemented these recommendations—that is a question for the device’s own labeling.

How Do I Evaluate a Connected Device’s Interoperability?

Use this order when you are trying to understand how a connected device is meant to work, rather than assuming compatibility. If the labeling doesn’t name a specific standard, treat any interoperability claim as unverified until you can confirm it directly with the manufacturer.

1. Check the labeling or instructions for use first. Look for a named list of devices, apps, or systems the product is actually designed to connect with.
2. Ask which standard, if any, it follows. A stated standard (like DICOM or the 2800 series) gives you something concrete to verify, rather than a general compatibility claim.
3. Confirm what happens if the connection fails. Find out whether the device still performs its core function on its own, or depends on the connection to work at all.
4. Ask exactly what data is sent and where it goes. Get this from a privacy policy or notice you can actually read, not a general assurance.
5. Find out who is responsible for catching errors. Ask whether the device, the receiving system, or the user is expected to verify that transferred data arrived correctly.
6. Look for stated limits on use. Check whether the labeling restricts the settings or conditions under which the connection is intended to be used.

What Should I Do If a Connected Device Malfunctions?

If a connected device malfunctions in a way that affects your immediate health or safety, contact local emergency services or your health care provider first. A question framework like this one is for understanding a device’s design ahead of time—not for troubleshooting an active medical emergency.

Frequently Asked Questions

Is interoperability the same as FDA approval?

No. Interoperability describes the ability of devices to exchange information safely and effectively. The FDA’s role described in these sources is publishing guidance on design considerations and what to include in premarket submissions and labeling—not certifying that a connection will always work.

Does following a recognized standard commitment two devices will work together?

The FDA’s sources describe standards conformance as something that can help create systems of interchangeable devices from different manufacturers. They do not state that this is designed to deliver compatibility for any specific device pairing, so it’s worth confirming directly rather than assuming.

Why does the FDA care about device interoperability at all?

The FDA has said interoperable devices can improve patient care, reduce errors and adverse events, encourage innovation, and support more diverse research datasets. It has also flagged rising cybersecurity concerns as connectivity increases.

What year did the FDA start recognizing interoperability standards?

The FDA officially recognized its first set of interoperability-related standards in 2013 and has continued expanding that recognized list since, including standards updated as recently as 2022.

Where can I read the FDA’s actual interoperable-device guidance?

The FDA’s final guidance, Design Considerations and Pre-market Submission Recommendations for Interoperable Medical Devices, was issued in September 2017 and is publicly available directly from the FDA’s guidance document library, linked below.

Where Does This Information Come From?

This article is based on two current FDA sources: the FDA’s Medical Device Interoperability overview and the 2017 Design Considerations and Pre-market Submission Recommendations guidance. For more on how sources are checked for this site, see How We Research.

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Medical Information Disclaimer

This article is for general education only. It is not medical advice and does not diagnose, treat, or evaluate any specific device, condition, or connection. Always check a device’s own labeling and instructions for use, and talk with a qualified health care provider about decisions involving your care or your connected medical devices.

By Connected Diagnostics Evidence Editorial Team. Content current as of September 9, 2026, based on FDA source pages last updated April 22, 2024 and August 30, 2018.