Michael Kasser

Michael Kasser

Hogan Lovells

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Seeking to reduce premarket burdens, FDA proposes to expand Abbreviated 510(k) Pathway for certain devices

Building on recent efforts to streamline premarket review of medical devices, on April 12, 2018, the Food and Drug Administration (FDA) issued a draft guidance seeking to expand use of the historically underutilized...more

4/19/2018  /  510(k) RTA , FDA Approval , Food and Drug Administration (FDA) , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications
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