Zdrowie i gospodarka · 2.06.2003

Medical Devices; Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA; Availability

The Food and Drug Administration (FDA) is announcing the availability of the guidance entitled "Class II Special Controls Guidance Document: Resorbable Calcium Salt Bone Void Filler Device; Guidance for Industry and FDA." This document describes a means by which resorbable calcium salt bone void filler devices may comply with the requirement for special controls. Elsewhere in this issue of the Federal Register, FDA is issuing a final rule to classify the resorbable calcium salt bone void filler device into class II (special controls).