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Medical Devices FDA

Update on discontinuation of Essure, ongoing postmarket activities The FDA announced an update on safety monitoring for the device and that all unused Essure devices should have been returned by

Emergency Use Authorizations FDA

This page lists current Emergency Use Authorizations that make available medical devices to diagnose and respond to public health emergencies.

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Medical Device Exemptions 510(k) and GMP Requirements

Following is a breakdown of 510(k) exempt and Good Manufacturing Practice (GMP)/Quality System exemptions listed by device class. All devices in this list are 510(k) exempt unless further qualified by a footnote. Only devices annotated by (*) are also exempt from GMP except for general recordkeeping requirements and compliant files. Class I Devices

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