Little Known FDA Clearance Path Gains Steam
BY ELOISE AUSTIN, OCTOBER 9, 2008
The FDA "de novo" classification pathway is an often overlooked but potentially valuable regulatory clearance process for device manufacturers. The pathway involves a streamlined reclassification process for devices that are low-risk but have no sufficiently equivalent (NSE) predicate (i.e. have no similar device that has previously received 510(k) clearance). Therefore these low-risk devices, because of their novel nature, are automatically assigned a Class III status (typically for high-risk devices and requiring a much more onerous application process). Through the de novo pathway, novel low-risk devices can be reclassified to Class I or II, helping manufacturers to avoid the resource intensive and time-consuming process of Premarket Approval (PMA). A manufacturer must submit a request for de novo classification within 30 days of an FDA NSE determination. This reclassification pathway has been in existence since 1997, when it was included in that year's FDA Modernization Act.
Since its introduction, approximately 39 devices have been brought to market via this pathway. In the last two years, 6 devices have been approved, most of them for diagnostic purposes or physiologic monitoring (an ultrasound device for monitoring fetal heart rate and cervix dilation; absorbable sutures; a home test for loss of sense of smell; a computerized medication dispensing box; a respirator mask for public health emergencies; and an implantable intraaneurysm pressure measurement system). Most of the devices approved for de novo classification have been minimally to moderately invasive diagnostic test systems, suggesting that diagnostic tools or less invasive implants in the orthopedic sector are more likely to be eligible for this pathway than, for example, a novel spinal implant product. Overall, this pathway accounts for a very small number of device applications annually, however de novo reclassification may be useful in the orthopedic sector should a novel device with the right set of characteristics emerge.
