The U.S. Food and Drug Administration (FDA) places devices into three classifications based on the level of risk they pose to the patient: Class I for low risk, Class II for medium risk, and Class III for high risk. FDA requires different levels of evidence on safety and effectiveness for each class. For example, Class III devices generally have a higher evidence burden than those in Classes I or II. Under current law, any novel device (i.e., one not substantially equivalent to an existing device) is automatically assigned to Class III, regardless of its risk profile.
In an attempt to remediate the inefficiency requiring that innovative lower-risk devices meet the same rigorous standards as Class III devices, Congress established the two-step de novo process in 1997. The first step is the same used by most Class II devices to enter the marketplace: an application to FDA demonstrating that the device is “substantially equivalent” to another device in use. However, for those cases in which it’s clear to both the manufacturer and FDA that a device is dissimilar to anything already on the marketplace, this step is both unnecessary and cumbersome. Only after FDA makes a determination that the device is unlike any other device already on the marketplace can the manufacturer then proceed to the second step - the de novo petition - requesting lower-risk reclassification and entry into the marketplace.
The de novo process as it exists now is not achieving its purpose of streamlining the path to move new devices onto the marketplace and has instead added unnecessary and time-consuming requirements. On average, FDA has taken over 250 days to approve a de novo petition every year from 2005 to 2009. In part because of this administrative inefficiency, the Institute of Medicine found that only 119 de novo petitions had been received between 1998 and 2009 and determined that “the de novo process has not met its potential as an alternative regulatory pathway for moderate-risk but novel medical devices.