Brandon von Kriegelstein

Brandon von Kriegelstein

Katten Muchin Rosenman LLP

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FDA Requesting Comments on Proposed Guidance Regarding 510(k) Transfers

On June 5, 2025, the U.S. Food and Drug Administration (“FDA”) issued draft guidance (the “510(k) Transfer Guidance”) related to the transfer of a Premarket Notification (510(k)) Clearance. The 510(k) Transfer Guidance...more

6/30/2025  /  Comment Period , Food and Drug Administration (FDA) , Manufacturers , Medical Devices , New Guidance , Proposed Rules , Regulatory Oversight , Regulatory Requirements , Supply Chain
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