Class I Medical Device

FDA Requests Public Comment on Classifying Certain Medical Device Accessories as Class I Devices

The FDA’s Center for Devices and Radiological Health has issued a proposed list of medical device accessories that may be eligible for independent classification as Class I devices and opened a comment period through October 16, 2026. The action does not mean that the classification has already been approved; rather, it aims to identify accessories for which general controls are sufficient to provide reasonable assurance of safety and effectiveness.