On the recordMarch 28, 2012
It does seem like using a flawed design as a foundation for approving another device under 510(k) is something that we need to wrestle with.
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congress.govIt does seem like using a flawed design as a foundation for approving another device under 510(k) is something that we need to wrestle with.
Merkley expresses concern over approving devices based on recalled designs.
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