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FDA Faces Challenges In Writing Reg For 510(k) Transfers Of Ownership

FDA’s device center thought a planned proposed regulation for requiring 510(k) transfer-of-ownership updates would be a “pretty simple idea,” but it turned out to be more complicated than expected.

In developing a proposed regulation intended to improve how transfers of ownership of 510(k) clearances are updated in FDA’s systems, CDRH says it faces problems making the process both entirely electronic and least burdensome for companies.

As of now, the device center says it plans to link the 510(k) database with its registration and listing

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