Medical Devices; Exemptions From Premarket Notification: Class II Devices; Request for Comments
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Document details are published in the U.S. Federal Register; SPEQ surfaces them for reference and is not affiliated with or endorsed by the FDA or the Office of the Federal Register. The authoritative text is on federalregister.gov.
The Food and Drug Administration (FDA) has identified a list of class II devices that, when finalized, will be exempt from premarket notification requirements, subject to certain limitations. FDA is publishing this notice and requesting public comment in accordance with procedures established by the 21st Century Cures Act. This notice does not represent FDA's final determination with respect to the devices included in this document. FDA will review any comments submitted within the 60-day comment period and will consider whether the list of class II devices should be modified prior to publication of its final determination in the Federal Register.
Abstract as published in the Federal Register.
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