Table 1.

Center for Devices and Radiologic Health device risk classification with hemodialysis vascular access device examples

Device ClassRisk LevelDevice Class RequirementsHD Vascular Access ExampleRegulatory Pathway (for Example)Comments
1LowGeneral controlsaManual surgical instrument (e.g., scalpel, hemostat)Exempt from premarket notificationRegulation (21 CFR 878.4800)b
2Low to moderateGeneral controlsa; special controlscVascular graft prosthesisPremarket notification [510(k)]Regulation (21 CFR 870.3450)d; the special control for this device is the FDA guidance document entitled “Guidance Document for Vascular Prostheses 510k Submissions”e
3HighGeneral controlsa; PMAfBovine carotid artery arterial graft prosthesisgPMAfPMA approval is on the basis of a determination by the FDA that the PMA contains sufficient valid scientific evidence to assure that the device is safe and effective for its intended use(s)f