FDA Guidance would Reclassify Implanted Blood Access Devices to Class II (Special Controls)
New draft guidance from the US Food and Drug Administration (FDA) would allow reclassification of implanted blood access devices for hemodialysis procedures to Class II (special controls).
Implanted blood access devices qualifying for reclassification include A-V shunt cannula (Product Code FIQ); vessel tips (FKW); single-needle (co-axial flow) dialysis sets (LBW); subclavian catheters (LFJ); implanted hemodialysis catheters (MSD); implanted triple-lumen hemodialysis catheters (NIF); and implanted coated hemodialysis catheters (NYU).
If the FDA finalizes the guidance, manufacturers of such devices will need to address special control requirements in their 510(k) applications. The agency recommends that manufacturers provide the following information:
- Classification name
- Common name
- Trade/proprietary name, including lists of model numbers
- Clear description of device’s intended use
- CFR classification number under which you believe your device will be regulated
Valid predicate device comparisons, device materials and biocompatibility, adequate performance testing and labeling information should also be included in affected manufacturers’ premarket notification submissions.
Comments on the FDA’s draft guidance will be accepted through the next 90 days.