The FDA’s draft guidance on the de novo classification process is finally available for comment purposes.

A little over a year ago, the FDA’s 510(k) working group issued a preliminary report recommending significant changes following its internal assessment of the 510(k) process. One of the areas recommended for improvement was the existing de novo process due to its underutilization as a way to get new devices to market.

Although the FDA acknowledged that Congress intended the de novo review process to be an alternate means to market new devices independent of the premarket approval (PMA) or 510(k) process, actual implementation prevented parties from using this avenue. The quandary many device companies faced was that devices not suited for 510(k) review, often because no similar predicate existed, still had to go through the 510(k) process and obtain a “not substantially equivalent” (NSE) letter before the company could submit a de novo application. Manufacturers were therefore forced to attempt to fit their device into the 510(k) regulatory scheme—knowing full well it was inappropriate—just to position themselves to use the more appropriate de novo process.

The FDA is now attempting to remedy this problem by allowing manufacturers to communicate with the FDA before attempting to submit a 510(k) for a device with no appropriate predicate. In August 2010, the working group noted that the FDA should “establish a mechanism for early collaboration with the manufacturer and an expedited process for initiating review of de novo requests” and “issue additional guidance on the threshold for clearing a device through the de novo process.” It appears that with this draft guidance the FDA is taking steps in this direction.

At Hodgson Russ, we have encountered problems helping our clients make use of the de novo process, particularly when there is no suitable predicate. Up to this point, it was impossible to know how to properly submit a 510(k) in the absence of a predicate. Now, the FDA proposes to allow de novo review via two pathways, the first of which is new:

  1. Submitting a pre de novo submission (PDS)
  2. Submitting a traditional 510(k)

With the new PDS pathway, manufacturers may interact with the FDA early in the device development process. The information the FDA requires in a PDS, specified in attachment three of the draft guidance, includes:

  • The manufacturer’s device classification recommendation
  • Whether the manufacturer thinks the device should be 510(k) exempt
  • All protocols for bench and clinical testing (and any test results, if available)
  • Information supporting the effectiveness of the device
  • A list of potential risks
  • A classification summary

The classification summary provides the “out” for manufacturers with no suitable predicate. The FDA instructs manufacturers to “[d]escribe why the new device does not have a predicate device, fit into an existing classification regulation, or be of a type that has been approved in a PMA. For potential predicate devices with similar technology and/or indications, include discussion of why the new device is not substantially equivalent.”

In the end, manufacturers must still submit a 510(k), but this new process has two benefits. First, it permits early discussion and guidance from the FDA. Second, it permits simultaneous submission of a 510(k) and a de novo request in a concurrent de novo petition process.

One issue that remains is how to choose predicates for the 510(k) if devices are truly novel. The only option in the past has been the use of split or multiple predicates. Now, the FDA advises that sections of the 510(k) which are inapplicable be designated with “we are seeking concurrent FDA review or de novo petition.” This may be one area in which the FDA could provide more guidance to further improve both the use of its resources and the de novo review process.

Interested parties can submit comments on this guidance until December 2, 2011, as outlined in the October 3, 2011 Federal Register.