Zdrowie i gospodarka · 08/02/2008

FDA Proposes to Reclassify Medical Device Data System from Class III to Class I

The Food and Drug Administration (FDA) is proposing to reclassify the Medical Device Data System (MDDS) from a class III device requiring premarket approval to a class I device subject to general controls, excluding devices with new diagnostic or alarm functions, and proposing exemptions for MDDS used by healthcare professionals without irreversible data compression.