On the recordNovember 14, 2011
I've heard from large and small companies in my State that your guidance relating to the modifications of the 510(k) process for devices is of concern.
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congress.govAl Franken: “I've heard from large and small companies in my State that your guidance relating to the modifications of the 510(k)…”
Editor's note · Context
Franken highlights concerns from companies about the clarity of FDA's guidance on device modifications.
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