FDA Seeks Feedback on Distinct Classification of Existing Device Accessories into Class I

FDA Seeks Feedback on Distinct Classification of Existing Device Accessories into Class I

FDA's Center for Devices and Radiological Health (CDRH) issued a request for public comment on December 5, 2025, seeking feedback on the distinct classification of existing medical device accessories into Class I. The notice reflects FDA's ongoing efforts to classify accessories based on their own risks and necessary controls, not merely by reference to the parent device's class. Comments are due by February 3, 2026, at Docket No. FDA-2025-N-6224