Zdrowie i gospodarka · 01/09/1995

Medical Devices; Proposed Reclassification and Exemption From Premarket Notification for Certain Classified Devices; Correction

The Food and Drug Administration (FDA) is correcting a proposed rule that appeared in the Federal Register of July 28, 1995 (60 FR 38902). The document proposed to reclassify 112 generic types of class II devices into class I based on new information respecting the devices, and exempt the 112 generic types of devices, along with 12 already classified generic types of class I devices, from the requirement of premarket notification, with limitations. The document was published with some errors. This document corrects those errors.