Draft Guidance for Industry and Food and Drug Administration Staff; Medical Devices: Radiology Devices; Class II Special Controls Guidance Document: Bone Sonometers; Availability

概要

The Food and Drug Administration (FDA) is announcing the availability of a draft guidance for industry and FDA staff entitled "Class II Special Controls Guidance Document: Bone Sonometers." The draft guidance was developed to support the reclassification of bone sonometers from class III (premarket approval) into class II (special controls). Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify these devices accordingly. This draft guidance is neither final nor is it in effect at this time.