FDA Publishes List of Devices With Update Protocols
You can now view which of the 240 listed medical devices are authorized to receive software updates without new filings.
Updated on Oct. 22, 2026 in Diabetes
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In October 2026, the FDA launched a website detailing 240 medical devices that utilize predetermined change control plans. This resource allows the public to track which devices, including those used for diabetes care, have authorized protocols for modifications without additional regulatory filings.
Why it matters
These plans aim to streamline how medical technology is updated while maintaining safety oversight. For patients, knowing which devices utilize these plans offers transparency into how their health technology evolves and receives software improvements over time.
The FDA registry confirms 240 devices have authorized predetermined change control plans, with 41 of these held by Medtronic and MiniMed. The specific impact of these individual software modifications on clinical outcomes remains subject to ongoing manufacturer monitoring.
The players
FDA
The federal agency responsible for protecting public health by ensuring the safety and efficacy of medical devices.
Medtronic
A global medical technology company that develops treatment systems for diabetes and other chronic conditions.
MiniMed
A division of Medtronic focused on developing advanced insulin delivery systems and continuous glucose monitors.
The details
Predetermined change control plans allow manufacturers to pre-specify future device modifications and how they will be validated. By securing FDA authorization for these plans during initial approval, companies can implement updates to software without submitting a new marketing application for every change. This mechanism is designed to accelerate the deployment of improvements to medical equipment while ensuring each modification still adheres to established safety standards.
Timeline
October 2026: The FDA announced the new website for authorized device plans.
September 30, 2026: The FDA device list was updated to be current through this date.
Health Landscape
This initiative follows the framework of the FDA's Predetermined Change Control Plans program to modernize medical device regulation. It reflects a shift toward more flexible, software-centric oversight for long-term health technology.
If you use a medical device for diabetes management, you can check this registry to see if your current equipment operates under a predetermined change control plan. It is worth discussing with your doctor how software updates for your specific device are communicated to you.
The takeaway
The FDA is increasing transparency by listing devices that use pre-authorized update plans. Patients using medical technology should keep track of device software versioning and consult their physician if they notice changes in device behavior or data interface.
Further reading
For more on how new technologies are impacting your care, explore our Diabetes section.
Source note: This article includes information reported by Insights.
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