Draft Guidance for Industry and Food and Drug Administration Staff; Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty Catheters; Availability

摘要

The Food and Drug Administration (FDA) is announcing the availability of the draft guidance for industry and FDA staff entitled "Class II Special Controls Guidance Document for Certain Percutaneous Transluminal Coronary Angioplasty (PTCA) Catheters." The draft guidance was developed as the special controls to support the reclassification of PTCA catheters, other than cutting/scoring PTCA catheters, from class III (premarket approval) into class II (special controls). This draft guidance describes a means by which PTCA catheters, other than cutting/scoring PTCA catheters, may comply with the requirement of special controls for class II devices. Elsewhere in this issue of the Federal Register, FDA is issuing for public comment the recommendation of the Circulatory System Devices Panel (the Panel) to reclassify PTCA catheters, other than cutting/scoring PTCA catheters, from class III to class II. This draft guidance is not final nor is it in effect at this time.