Product Licensing
U.S. FDA changes classification of semi-automated whole blood separation system
Published in Medical Letter on the CDC and FDA, January 2nd, 2005
The U.S. Food and Drug Administration (FDA) has determined that the TPD is not substantially equivalent to devices marketed in interstate commerce prior to May 28, 1976 or to any device which has been reclassified into class 1 or class 2 and therefore, the TPD has been classified by statute into class 3 (pre-market approval, PMA). ThermoGenesis is consulting with the FDA to determine whether the company will file a reclassification submission or a PMA. A PMA submission typically takes the FDA approximately 6 months to...
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