Zdrowie i gospodarka · 15/03/1999

FDA Proposes to Reclassify 38 Medical Devices from Class III to Class II

The US Food and Drug Administration (FDA) is proposing to reclassify 38 preamendments class III medical devices into class II, which will require special controls to ensure their safety and effectiveness, based on new information and amendments to the Federal Food, Drug, and Cosmetic Act.