The Food and Drug Administration has deemed certain medical devices as being safer than they previously were.
The agency has just released draft guidance which concerns a type of medical product known as an implanted blood access device. Such technology usually takes the form of cannulae, catheters, and hollow needles that work by placing a tube within a vein that enables blood to be removed and cleaned when a patient is hooked up to a dialysis machine.
Previously, these types of devices had been classified as a Class III device, which is the designation given to those items that pose the greatest risk to individuals. It’s been this way since 1983, owing to the fact that the FDA wanted more data that supported the safety of the devices. Since that time, though, the FDA has become somewhat lenient toward the devices, letting manufacturers gain approval by filing for a 510(k) clearance, which lets a device skip clinical trials.
Now, though, the FDA is making that leniency official by reclassifying the blood access devices as Class II. Because the FDA has been basically treating the devices this way for years, they predict that there won’t be much of a change in regulation and marketing. They believe that special controls already in place are sufficient to ensuring safety among consumers who have these devices implanted.