The FDA's release of the de novo draft guidance last week is causing a stir, but does the newly created concurrent review really help save cost and time?  We've gone through the mechanics of the draft guidance to help companies better understand their options and the true time and cost savings.

Eligibility: The new pre de novo submission (PDS) pathway is available only to low or moderate risk devices for which there is not a suitable predicate (this may include situations where stacked or multiple predicates may have been used under the previously available process).

When to contact the FDA: After the intended use and key features of the device are finalized.

How to contact the FDA: Companies have two options—initiate contact with a PDS or follow the preexisting process (i.e., submit a traditional 510(k)).

PDS content: Much of the content is similar to the 510(k) sections, including device description and performance data plans (or results). An additional component is the classification recommendation, which requires the submitter to propose a classification, including any special controls that may be appropriate. Another key addition is the focus on risk and mitigation in the PDS. Companies should be prepared to address areas of risk with appropriate mitigation proposals. Finally, companies will need to identify potential predicates—those that might have been the basis for a "cross your fingers" 510(k) previously—and then must discuss why those predicates do not quite fit the bill.

PDS review timing: The FDA will request additional information (AI)—a familiar breed of requests for those familiar with the 510(k) process—within 60 days of a PDS submission. There may be multiple AI requests. Once all AI requests are satisfied and the FDA has "all information necessary," then a suitability letter will be sent within 60 days.

PDS review outcome: The suitability letter will convey the results of the FDA's PDS review and identify if the device is suitable for de novo review. Perhaps the most obvious benefit for companies provided through this draft guidance lies in this particular step. Submission of a PDS and the issuance of a suitability letter might make discussions with investors more comfortable and may provide the assurances many in the investment community are currently looking for. We suggest companies consider this suitability letter to be a key milestone for additional funding.

De novo suitability: If a company’s device is found suitable, the company may opt to submit a 510(k) followed by the de novo petition, or to submit the two concurrently.

Concurrent review benefits: If the concurrent path is utilized, timing for review should decrease—slightly. The FDA plans to conduct a screening review within 20 days and issue a not substantially equivalent (NSE) determination on the 510(k) in another 60 days (total of 80 days). The FDA will file the de novo petition concurrent with issuing the NSE (another 30 days saved, since companies previously had 30 days from the NSE to file the de novo petition).

Additionally, the concurrent review should help curb the trend we have encountered in which the FDA denies the de novo petition after the NSE decision because the same 510(k) review team evaluated both submissions and allowed their NSE decision to affect their evaluation of the de novo petition. Although the review team may be the same, this new process should make it clear that the 510(k) is a means of conveying information and not a true request for premarket approval under Section 510(k).

Concurrent review difficulties: If the FDA's AIs under the 510(k) review identify information that will impact the concurrently submitted de novo petition, there may need to be amendments to the de novo petition. The FDA has not clearly identified how it will deal with that situation. Additionally, the FDA indicates that the de novo suitability letter is not necessarily binding. If the FDA is aware of a device that can serve as a predicate, it will switch the review to a traditional 510(k) only. So companies in the concurrent review process will want to deploy market intelligence to track whether potential predicates are working their way through the de novo process too.

Final de novo decision: The FDA will begin reviewing the de novo petition at the time it issues the NSE.  The FDA can also respond with AIs during this review, but if no AIs are issued (which should be the result after so many reviews of the device!) the review cycle is 60 days.

Time savings: Since the PDS requires information at a fairly final stage and could take anywhere from 60 to more than 120 days (depending on the number of AI requests), any savings gained in the concurrent review (which we estimate to be 40 days gained if there are no AIs during the concurrent review) will be lost, and will still require the standard 60 day review time for the de novo petition. If everything goes smoothly, the time frame from submission of PDS to de novo petition decision should be 120 days if there are no AIs and the company is able to submit the concurrent 510(k) and de novo petition on the same day they receive the suitability letter from the PDS. Under the traditional process, if everything goes smoothly, the time frame from submission of the 510(k) to the de novo decision is 150 days if there are no AIs and the company is able to submit the de novo petition on the same day it receives the NSE determination.

Cost savings: Technically, it can be argued that there is a 30 day time savings. However, under the newly designed concurrent review, a company interacts with the FDA much earlier in the process and is subjected to three distinct review periods where AIs can be issued by the FDA. Add to that the additional intellectual investment (whether internally or through contracted professionals) needed to prepared the PDS and navigate this process. We suspect cost savings may not actually materialize.