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# AdvaMed Recommendations for Class 2 Notification Exemption
- URL: https://www.fdaweb.com/advamed-recommendations-for-class-2-notification-exemption/
- Published: 2026-04-16T12:00:00.000Z
- Updated: 2026-09-14T13:37:31.000Z
- Author: David McFarland
- Tags: Devices, #legacy-id-D5160995

AdvaMed says it supports FDA’s effort to implement the 21st Century Cures Act by appropriately expanding exemptions from premarket notification for Class 2 devices where a 510(k) submission is not necessary to provide reasonable assurance of safety and effectiveness. In a comment [letter](https://downloads.regulations.gov/FDA-2026-N-0232-0015/attachment%5F1.pdf?ref=fdaweb.com), the industry trade association:

- says it fully supports the agency’s list of proposed exempt Class 2 devices subject to stated general limitations; and
- encourages FDA to eliminate the blanket IVD (*in vitro* diagnostics) limitation of exemption to align with the statute and remove unnecessary regulatory barriers on IVD devices.

AdvaMed also submits line-by-line specific comments on the devices listed for exemption.