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Exemptions › Premarket Approval Applications

Knobbe Martens

Certain Medical Devices Exempted from 510(k) Requirements

Knobbe Martens on

The Food and Drug Administration (FDA) recently identified a list of Class II Medical Devices that, when finalized, will be exempt from premarket notification (510(k)) requirements. This publication was made by the FDA...more

Mintz - Health Care Viewpoints

Cures Act Developments: FDA Proposes Class II Device Exemptions

Mintz - Health Care Viewpoints on

Since the 21st Century Cures Act became law on December 13, 2016, we have been blogging on regulatory and clinical areas affected by its provisions. On March 14, 2017, FDA made further progress on its Cures Act obligations by...more

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