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Zdrowie i gospodarka · 01/09/1995

FDA Corrects Proposed Rule on Medical Devices Reclassification and Exemption

The FDA is correcting a proposed rule from 1995 that aimed to reclassify 112 generic class II devices into class I and exempt 124 devices from premarket notification requirements due to new information, but the document contained errors, which are now being addressed.

Source: Federal Register — Food and Drug AdministrationOpen original release →