Zdrowie i gospodarka · 30/06/2004

Guidance for Industry and FDA Staff; Draft Class II Special Controls Guidance Document: Dental Bone Grafting Material; Availability

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance document entitled "Class II Special Controls Guidance Document: Dental Bone Grafting Material." Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify tricalcium phosphate granules for dental bone repair from class III (premarket approval) to class II (special controls) and to classify other dental bone grafting materials into the same class II (special controls) classification identification. The draft guidance describes a means by which dental bone grafting material devices may comply with the requirement of special controls for class II devices. This guidance is neither final nor is it in effect at this time.