The recently passed FDA Safety and Innovation Act makes major changes to the de novo reclassification process for medical devices. Namely, the new law mandates that a manufacturer can simply submit a request to the FDA for de novo classification without having a previously rejected 510(k) application.
Medical devices are classified in a three-tiered classification system based on risk and the types of controls needed to assure safety. Class I devices are the lowest risk, require only general controls, and typically do not require premarket notification or approval. Class II devices are moderate risk, require general and special controls, and typically require a 510(k) application. A 510(k) is a premarket submission that demonstrates that a device is substantially equivalent to a legally marketed device that is not subject to premarket approval (called a “predicate device). Class III devices are considered to have the highest risk and require general controls, special controls, and premarket approval.
If a low to moderate risk product does not have a predicate device, it receives an automatic Class III designation. The de novo classification process is a means to reclassify these devices from a Class III to a Class II or I designation. The de novo process was initially passed in the Food and Drug Administration Act (FDAMA) of 1997. It requires that a manufacturer submit a 510(k) premarket notification, which will undergo a full review considering “all aspects of the device”, before the device can receive the necessary Not Substantially Equivalent (NSE) designation. If the device is deemed NSE because a predicate device could not be found, the automatic Class III designation applies. The device manufacturer can then submit a de novo request to the FDA to have the product reclassified. After a substantive review of the request, the FDA will allow the product to be cleared under a 510(k).
If this seems to you like a complicated way to get the FDA to agree that there is no predicate device, you’re right. As of September of 2010, only 54 devices had been successfully classified as de novo devices. Additionally, de novo devices that were cleared between 2007 and 2010 had an average de novo review time of 240 days and an average total review time of 482 days, which is over 3 times longer than the 150 day review goal for 510(k)s.
The new de novo process mandated in FDASIA simply requires that manufacturers submit a request to the FDA for de novo classification. If the manufacturer is seeking Class II classification, a draft proposal for the applicable special controls should also be included. The FDA has 120 days to issue a decision on classification.
If all goes as planned, the new de novo classification process, which does not require a 510(k) submission and review, should dramatically increase the number of applicants seeking de novo classification and decrease the time of de novo review.
- FDASIA, Part 2: Pediatric Drugs and Devices and Medical Device Regulatory Improvements (ask-cato.com)
- Unique Device Identifiers: It’s the Law, Almost (ask-cato.com)