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Draft Guidance Aims to Demystify 510(k) Ownership

The proposed guidance explains how FDA tracks 510(k) clearance ownerships, and the agency’s actions and requirements during disputed 510(k) listings.

FDA published a draft guidance Dec. 22 in the form of a Q&A document to clarify how it tracks 510(k) clearances that change ownership. While 510(k) clearance transfers usually happen without significant problems, the agency has not previously provided much insight into how it tracks such transactions and how it addresses disputes about who owns the 510(k).

FDA usually gets notifications from companies claiming a 510(k) clearance has been transferred to them from a previous owner, but the agency admits that tracking the transfers has been challenging...

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