De novo requests are becoming an increasingly important premarket pathway option for medical devices, particularly those involving novel technologies. First established under the Food and Drug Administration Modernization Act of 1997, the de novo reclassification process was intended as a less burdensome premarket pathway for novel devices that had not previously been classified by FDA and, thus, were considered Class III by default. However, this process was long viewed by both industry and FDA as a less desirable premarket review option.
Posted with the permission of FDLI.