On the recordAugust 3, 2009
A supplemental PMA, which is required for any change of any kind, is required to be approved by FDA, using the same standards of safety and effectiveness as the original PMA.
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congress.govOrrin Hatch: “A supplemental PMA, which is required for any change of any kind, is required to be approved by FDA, using the same…”
Editor's note · Context
Hatch emphasizes that changes to devices must meet the same safety standards as originals.
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