On the recordNovember 14, 2011
But this issue of totally replacing the 510(k) gives us pause, and I think one of the reasons it gives us pause is the looming question of who would design the new system?
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congress.govBarbara Mikulski: “But this issue of totally replacing the 510(k) gives us pause, and I think one of the reasons it gives us pause is the…”
Editor's note · Context
Mikulski expresses concern over replacing the 510(k) system and who would design a new one.
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