De Novo Application Process
The 510(k) process is generally the preferred route for IVD companies. However, to obtain 510(k) clearance requires demonstrating “substantial equivalence” to a “predicate device.” For newer IVDs, there may not be a clear predicate device. The de novo process provides a solution, essentially allowing low and moderate risk devices to go through the 510(k) process despite the lack of a predicate.
FDASIA tries to improve the de novo process. Previously, a sponsor had to submit a 510(k) notification to FDA and receive a “not substantially equivalent” letter before submitting a de novo petition, even if the sponsor and FDA knew no appropriate predicate device existed. Moreover, there was no way to definitively find out in advance whether FDA would agree the product was eligible for de novo review.
FDASIA allows a sponsor to ask FDA if an IVD can go through the de novo process without first submitting a 510(k). FDA can agree that the de novo route is appropriate. Alternatively, FDA could identify a predicate device that the company could use. This action would mean there is no need for the de novo process because a traditional 510(k) can be used instead.
On the other hand, CDRH can decide that there is no predicate and the product is not eligible for de novo review if it finds that the device is not “low-moderate” risk or that general controls would be inadequate to control risks and special controls cannot be developed. Unless overturned, this decision means a PMA will be necessary.
This provision could have a significant positive effect. It creates a vehicle for IVD companies to learn early on whether the de novo pathway is open, a 510(k) can be submitted, or a PMA will be required. Many novel IVD products lack clear-cut predicate devices.
Unfortunately, because Congress gave FDA 120 days to respond to the request, the process may not provide speedy answers for sponsors. Even so, gaining that information early in the process could be helpful. Moreover, Congress’ actions may encourage FDA to use the de novo process more.
FDASIA contains other provisions that may be relevant, such as expanding the Humanitarian Device Exemption Program for products for rare diseases, modifying FDA’s device recall program, and reinforcing the importance of the “least burdensome” standard.
In addition, FDA has committed to new user fee goals, which should result in faster decision making. One direct effect is FDA’s issuance of a Refuse to Accept draft policy for 510(k)s. Companies submitting 510(k)s should carefully examine this checklist before sending their notification to FDA.
FDASIA does not revolutionize FDA regulation of IVDs. However, some of the provisions may offer significant benefits to IVD companies. Companies therefore should evaluate what impact the law may have on their regulatory situation and how to use the law to their advantage.