FDA Drafts Guide for Transferring 510(k) Medical Device Clearances
Published Date: 6/5/2025
Notice
Summary
The FDA just shared a draft guide to help companies understand how to transfer their 510(k) clearance when ownership changes. This is for businesses that make medical devices and want to pass their approval to someone else. It’s not final yet, so no changes or fees happen now, but it’s a heads-up for future updates.
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