Zachary Messick

Zachary Messick

Knobbe Martens

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FDA on pace for a Record Number of Breakthrough Devices in 2023

The FDA implemented the breakthrough device program in 2015. The program was designed to expedite review of premarket approval (PMA), 510(k) clearance, and De Novo marketing authorizations. Applicants can seek a breakthrough...more

7/21/2023  /  510(k) RTA , FDA Approval , Food & Drug Regulations , Food and Drug Administration (FDA) , Life Sciences , Medical Devices , Pharmaceutical Industry , Premarket Approval Applications
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