Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
Published Date: 2/6/2026
Notice
Summary
The FDA is thinking about letting some medium-risk medical devices skip a step called premarket notification, which means faster and easier approval. They want to hear from the public by April 7, 2026, before making a final decision. This could save time and money for device makers and get helpful devices to patients quicker.
Analyzed Economic Effects
3 provisions identified: 1 benefits, 2 costs, 0 mixed.
Listed Class II Devices May Be Exempt
FDA proposes that the class II device types listed in Table 1 and Table 2 would no longer require premarket notification under section 510(k) if the proposal is finalized. FDA says this final action "will decrease regulatory burdens on the medical device industry and will eliminate private costs and expenditures" because manufacturers "will no longer have to invest time and resources in 510(k) submissions" for exempt devices.
Exemptions Limited; Some Devices Still Need 510(k)
FDA proposes partial limitations so that only devices meeting specified conditions would be exempt; devices that fall outside those partial limitations would remain subject to 510(k). For example, a uterine tenaculum would be exempt only if it is a manual mechanical device, and powered uterine tenacula (such as vacuum-based devices) would still require premarket notification.
New Product Codes for Exempt Devices
If exemptions are finalized, FDA will assign new product codes to device types that become exempt so they can be identified separately from devices that remain subject to 510(k). Exempt and non-exempt devices within the same device type will therefore have different product codes.
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