Political Quotes

Dan Coats: “They made a change in the ``indication'' and ``contraindication'' in accordance with what FDA asked them to do. They…”

On the recordSeptember 23, 1997
They made a change in the ``indication'' and ``contraindication'' in accordance with what FDA asked them to do. They resubmitted for a new 510(k). FDA, with the help, apparently of Senator Kennedy and his staff, approved the 510(k) and then the new 510(k) was applicable. So that is exactly how FDA is supposed to work and it did work under the existing procedures. Again, over and over and over, what has not been described and discussed is the authority that the FDA has regarding changes in technology that raised questions of safety and efficacy, effectiveness of the predicate device.
Said by
Dan Coats
Republican · Indiana
Source
govinfo.gov

Editor's note · Context

Discussing the FDA's approval process for medical devices.

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