So it appears that the failure of this product is not due to 510(k) process but to regulatory inaction by our own FDA.
Phil Gingrey: “So it appears that the failure of this product is not due to 510(k) process but to regulatory inaction by our own FDA.”
Editor's note · Context
Gingrey argues that regulatory inaction, not the 510(k) process, caused issues with medical devices.
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