Table 1.
Center for Devices and Radiologic Health device risk classification with hemodialysis vascular access device examples
| Device Class | Risk Level | Device Class Requirements | HD Vascular Access Example | Regulatory Pathway (for Example) | Comments |
|---|---|---|---|---|---|
| 1 | Low | General controlsa | Manual surgical instrument (e.g., scalpel, hemostat) | Exempt from premarket notification | Regulation (21 CFR 878.4800)b |
| 2 | Low to moderate | General controlsa; special controlsc | Vascular graft prosthesis | Premarket 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 |
| 3 | High | General controlsa; PMAf | Bovine carotid artery arterial graft prosthesisg | PMAf | PMA 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 |
HD, hemodialysis; CFR, Code of Federal Regulations; FDA, US Food and Drug Administration; PMA, premarket approval.
General controls are regulatory requirements authorized by the Federal Food, Drug, and Cosmetic Act under sections 501 (adulterated devices), 502 (misbranded devices), 510 (registration and listing), 516 (banned devices), 518 (notification and other remedies), 519 (records and reports), and 520 (general provisions). General controls apply to all medical devices, unless exempted by regulations. If a device is exempted from one of the general controls, such exemption is stated in the classification regulation for that device.
Special controls are regulatory requirements for class 2 devices, for which general controls alone are insufficient to provide reasonable assurance of the safety and effectiveness of the device and there is sufficient information to establish special controls to provide such assurance. Special controls are usually device specific (e.g., performance standards, postmarket surveillance, patient registries, special labeling requirements, premarket data requirements, and guidelines).