Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document: Full Field Digital Mammography System; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance entitled "Class II Special Controls Guidance Document: Full Field Digital Mammography System." This draft guidance document describes a means by which the full field digital mammography (FFDM) system may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is publishing a proposed rule to reclassify the FFDM system device type from class III (premarket approval) into class II (special controls). This draft guidance is neither final nor is it in effect at this time.