Medical technology is changing faster than the rules that govern it. Yet the Food and Drug Administration (FDA) still relies on an outdated approval system built largely around reviewing discrete versions of products, even as many modern devices are designed to evolve. Such mismatch can delay patients’ and providers’ access to safer, more accurate, or more convenient medical technology.
FDA classifies devices by risk with varying levels of regulatory review. Many low-risk Class I devices are exempt from premarket review, including common tools such as tongue depressors and elastic bandages. Other Class I devices, most medium-risk Class II devices, and high-risk Class III devices may require review through one of three principal pathways: Premarket Notification, in which manufacturers generally must show that a device is substantially similar to one already legally marketed; De Novo classification for novel low- or moderate-risk devices without a suitable comparison; or Premarket Approval (PMA), the most demanding process, generally reserved for high-risk devices.
Premarket Notification uses a comparative standard, although manufacturers may still need to submit performance testing and other evidence. The De Novo process requires manufacturers to demonstrate that the device’s risks can be adequately addressed through appropriate regulatory controls.
| Pathway | Class | Requirements |
| Premarket Notification | Some Class I Most Class II | Show the device is substantially equivalent to a legally marketed predicate device. |
| De Novo | Novel low- or moderate-risk devices without a suitable predicate | Show the device can be safely regulated through general and, when necessary, special controls. |
| Premarket Approval (PMA) | Most high-risk Class III devices | Independently demonstrate a reasonable assurance of safety and effectiveness, often with extensive testing and clinical evidence. |
PMA goes further, requiring manufacturers to independently demonstrate a reasonable assurance of safety and effectiveness. That can require extensive laboratory testing, clinical evidence, manufacturing information, and detailed review of the device’s design.
More demanding regulatory requirements mean higher compliance costs, which can ultimately increase prices and reduce competition. Beginning October 2026, FDA’s standard fees are $28,653 for Premarket Notification, $191,020 for De Novo review, and $636,732 for PMA, before accounting for testing, clinical studies, legal work, and other regulatory compliance. Large manufacturers can spread those fixed costs across many products, but smaller innovators cannot. FDA offers discounted user fees to qualifying small businesses, but compliance costs are still high. FDA estimates the full cost of De Novo submission can be as much as $527,202, apart from the user fee.
The design of the approval process is particularly problematic for technologies meant to continuously improve. Reviewing a traditional mechanical device as a discrete finished product makes sense when it will remain largely unchanged for years. But software, AI, robotics, and connected devices can improve repeatedly after reaching the market. Significant improvements can trigger additional FDA review, and manufacturers may face higher costs for updating a device than leaving yesterday’s technology in place.
Thankfully, the FDA’s approval system has already shown it can accommodate technologies that evolve much faster than traditional medical devices. The FDA’s Predetermined Change Control Plan (PCCP) framework allows manufacturers to identify anticipated modifications in advance, explain how those changes will be developed and validated, and establish how their effects will be assessed. Once FDA authorizes the plan, covered changes can be implemented without another marketing submission as long as they satisfy the predetermined requirements.
However, it only applies to AI products. Not robotics, wearables, or any other modern medical technology. FDA has the power to change that.
Congress opened the door to broader reform in 2022, expressly authorizing FDA to approve PCCPs for medical devices generally. FDA finalized that guidance into a rule for AI in 2025, but for medical devices more broadly, the FDA is still sitting on 2024 draft guidance instead of a finalized plan.
FDA should finish the job by making PCCPs a routine option for hardware, robotics, wearables, imaging equipment, and other modern devices designed for iterative improvement.
Expanding PCCPs would allow manufacturers to improve devices faster without sacrificing safety. A surgical robot could receive software or control-system upgrades, a wearable could adopt better sensors or connectivity, and an imaging device could improve performance. All within preapproved parameters with established testing standards. Patients and providers could gain access to safer and more accurate tools sooner, while manufacturers would still have to meet FDA-approved testing and safety and performance requirements.
FDA already has the authority to let manufacturers plan and validate predictable updates in advance. It also has experience doing so. Expanding that approach would preserve safety standards while giving patients and providers faster access to improved medical technology and giving innovators more room to compete. In a field where technology can improve in months rather than years, patients should not have to wait for the regulatory system to catch up.
Justin Leventhal is a Senior Policy Analyst for the American Consumer Institute, a nonprofit education and research organization that advocates for consumers through evidence-based analysis and data. Follow Justin on X @JustinLeventhal