FDA Issues Final Order on Premarket Notification Exemptions

Today, the U.S. Food and Drug Administration (FDA) issued this final order: Medical Devices; Exemptions From Premarket Notification for Class I and Class II Devices. The FDA identified specific class I and class II medical devices that no longer require a premarket notification (510(k)) in accordance with the 21st Century Cures Act.  The notices of exemption for the identified devices were previously published in the Federal Register (82 FR 17841 and 82 FR 31976). This final order amends the Code of Federal Regulations (CFR) to reflect final determinations for these exemptions.

Read the Final Order Questions? If you have questions about this final order, contact the Division of Industry and Consumer Education .