Zdrowie i gospodarka · 14.08.2008
Medical Devices; Radiology Devices; Reclassification of Bone Sonometers
The Food and Drug Administration (FDA) is correcting a final rule that appeared in the Federal Register of July 17, 2008 (73 FR 40967). The final rule reclassified bone sonometer devices from class III into class II, subject to special controls. The document contained an inadvertent error regarding the impact of the final rule on small businesses. This document corrects that error.