Jordan Cox

Jordan Cox

Knobbe Martens

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FDA to Strengthen Cybersecurity Oversight

In a recent report, the U.S. Department of Health & Human Services (HHS) Office of the Inspector General (OIG) recommended that the U.S. Food & Drug Administration (FDA) include cybersecurity review as a greater part of the...more

10/1/2018  /  510(k) RTA , Cybersecurity , Department of Health and Human Services (HHS) , Food and Drug Administration (FDA) , Medical Devices , OIG , Popular , Premarket Approval Applications , Regulatory Requirements

Bills Introduced to Streamline FDA Review of Medical Devices

U.S. Senators Cory Gardner (R-CO) and Joe Donnelly (D-IN) recently introduced the Rare Device Innovation Act and the FDA Regulatory Efficiency Act.  The bills, if passed, would streamline the U.S. Food and Drug Administration...more

11/18/2015  /  510(k) RTA , Food and Drug Administration (FDA) , Medical Devices , Pending Legislation , Premarket Approval Applications , Rare Device Innovation Act
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