In July 2012, the Food and Drug Administration Safety and Innovation Act (FDASIA) was signed into law. The act makes major changes in the way certain medical devices are considered during pre-market review. The complex law made changes to the de novo reclassification process, based on the Latin term de novo which means “afresh” or “from the beginning.” In FDA language, “the de novo classification process provides a route to market for medical devices that are low to moderate risk, but that have been classified in Class III because FDA has found them to be ‘not substantially equivalent’ (NSE) to legally marketed predicate devices.”
In the FDA’s three-tiered classifications system, Class I medical devices such as bandages, examination gloves, and hand-held surgical instruments, are the lowest risk and do not require premarket notification or approval. Class II medical devices such as powered wheelchairs and pregnancy test kits, are a moderate risk and require general and special controls. Class III devices include pacemakers, external defibrillators and others considered to have the highest risk. These require special controls and premarket approval.
Manufacturers of certain Class II and Class III devices submit a 510(k) application. This premarket submission is meant to show that a device is a predicate device. That means it is substantially equivalent to an already marketed device and does not need premarket approval. If a Class I device does not compare to a predicate device it is automatically classified as a Class III device. This required Class I device makers to submit a 510(k).
Before the FDASIA was passed in 2012, manufacturers of low-risk products could avoid the 510(k) process if they submitted a de novo request to reclassify their devices from Class III to Class I. The average de novo review time was 480 days and between 2007 and 2010 only 54 devices were successfully reclassified. With the new law in effect, the de novo classification process is meant to be simpler. Manufacturers do not have to submit a 510(k) and the FDA is required to make a decision within 120 days. The new regulatory pathway has increased the number of applicants seeking de novo classification for medical devices while decreasing the timeframe for review.