“De Novo” pathway- Established by the Food and Drug Administration Modernization Act of 1997 to provide a new mechanism for reclassification of certain lower risk devices from class Ⅲ to class ⅠorⅡ.
Examples of De Novos Granted for Devices Presentng More Than Low Risk
De novo pathway is not just for low risk devices—
1. Neurovascular mechanical thrombectomy device for acute ischemic stroke
2. High intensity ultrasound for prostate tissue ablation
3. Assay for determination of procalcitonin in serum/plasma to aid in assessment of patients with suspected sepsis.
4. Esophageal thermal regulation device.