FDA Lists 240 Devices With Modified Change Plans
The agency released a directory of medical devices authorized to implement changes without additional marketing submissions.
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. These protocols allow manufacturers to update devices without the need for new regulatory marketing submissions.
Why it matters
This transparency effort clarifies which medical technologies can evolve through pre-authorized pathways rather than requiring full, recurring re-evaluations. By providing hypothetical software case studies, the FDA offers manufacturers a clearer roadmap for navigating these streamlined modifications.
The FDA currently lists 240 devices with predetermined change control plans as of September 30, 2026. Medtronic and MiniMed account for 41 of the total devices on this published registry.
The players
Food and Drug Administration
The federal agency is responsible for protecting public health by ensuring the safety and efficacy of medical devices and pharmaceuticals.
Medtronic
This global medical technology company specializes in the development of devices and therapies for chronic diseases.
MiniMed
The company is a major manufacturer of insulin pump systems and continuous glucose monitoring technology.
The details
The FDA website serves as a central repository for devices that have received authorization to bypass standard new marketing submission requirements for certain modifications. The agency included hypothetical software case studies on the site to help stakeholders understand how these change plans function in practice.
Timeline
The FDA list is current through September 30, 2026.
The agency announced the launch of the new website in October 2026.
The Big Picture
The agency's publication of this list follows the FDA's Predetermined Change Control Plan framework, which governs how software-based medical devices are maintained. This registry marks a transition toward more transparent oversight for adaptive medical technologies.
This list provides patients and providers with greater transparency regarding the software update paths for their medical devices. By understanding which devices utilize these plans, users can better track how manufacturers manage performance and security improvements over time.
The takeaway
The move toward a consolidated list of change-authorized devices reflects the agency's commitment to modernizing the regulatory pathway for software-heavy health technology. Patients should note that this transparency ensures manufacturers are operating within clearly defined, pre-approved modification limits.
Further reading
For more background on medical technology oversight, visit the United States Diabetes section.
Source note: This article includes information reported by Insights.
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