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Whose 510(k) Is It Anyway?

Summary by FDA Law Blog
FDA recently released a draft guidance regarding the transfer or sale of a 510(k) clearance. When a 510(k) for a device is sold or transferred from one entity to another, the new 510(k) holder must…
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FDA Law BlogFDA Law Blog

Whose 510(k) Is It Anyway?

FDA recently released a draft guidance regarding the transfer or sale of a 510(k) clearance. When a 510(k) for a device is sold or transferred from one entity to another, the new 510(k) holder must…

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FDA Law Blog broke the news in on Friday, July 25, 2025.
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