FDA Issues Draft Guidance Proposing to Streamline the de novo Classification ProcessOctober 3, 2011
On September 30, 2011, FDA announced the issuance of a Draft Guidance, De Novo Classification Process (Evaluation of Automatic Class III Designation), intended to update and streamline the de novo review process.
The de novo review process, formally known as Evaluation of Automatic Class III Designation, is established by section 513(f)(2) of the Federal Food, Drug, and Cosmetic Act ("FDC Act"), as amended. This process is a compromise between the 510(k) clearance process by which over 95% of medical devices come to market in the U.S., and the more rigorous premarket application ("PMA") approval process, generally reserved for higher risk devices. It was added to the FDC Act by the Food and Drug Administration Modernization Act of 1997 ("FDAMA") to address novel devices that lack a predicate device but pose only a low to moderate risk, making them ill suited to the PMA process.
Both FDA and industry agree that the de novo classification process has not been implemented very well, especially in recent years. We have blogged on the ballooning review times. It also has been difficult to get FDA to make timely decisions on whether a device is suitable for de novo review and what data requirements apply.
The Draft Guidance appears intended to address these failings. It states:
FDA believes that the process could be improved and greater clarity could be provided regarding suitability and data needed so that the de novo process may be a more viable pathway for novel low to moderate risk devices. Accordingly, FDA is issuing this draft guidance to provide updated recommendations for more efficient interactions with FDA, including what information to submit when seeking a path to market via the de novo process. This guidance describes a mechanism to provide (1) greater clarity about the suitability of a device for the de novo process, and (2) timely input on the type of data necessary to support de novo classification of a suitable device.
Under the statute, before a manufacturer may utilize the de novo process, it must submit a 510(k) notification to the agency, even if it knows no marketed predicate device exists. It then must wait for FDA to issue an NSE determination before it can file a petition for de novo classification. This requirement to submit a 510(k) notification and wait for an NSE determination, knowing that no valid predicate exists, significantly delays the process of classifying low- to moderate-risk devices through the de novo classification process.
The Draft Guidance proposes to transcend the statutory obstacle with a new administrative process, referred to as a “pre de novo submission,” or PDS. This voluntary process allows for early interaction between industry and FDA regarding whether a device is likely to be suitable for de novo classification. If FDA determines the device is likely to be suitable, the sponsor may then follow the initial review with concurrent submission of a 510(k) notification and de novo classification petition. As described in the Draft Guidance:
The purpose of the PDS is for us to analyze whether a new device appears to be suitable for the de novo process, and, if so, to provide an opportunity to advise you on the documentation needed in the subsequent 510(k) and de novo petition. The primary advantage of the PDS process is that it provides an early opportunity to obtain our assessment of the suitability of a new device for the de novo process, our preliminary perspective on the likely classification, as well as feedback on the evidence, including performance and/or clinical data, that will likely be necessary to support the de novo petition. By obtaining this early feedback, you are more likely to optimize your resources in collecting the necessary safety and effectiveness evidence needed to support a de novo petition, without the need to perform additional tests. This should also facilitate the review of a subsequent de novo petition.
After a PDS is submitted, FDA may request, within 60 days, any additional information it feels is needed. The sponsor also may submit a meeting request to discuss the PDS. FDA intends to issue a suitability determination within 60 days, after which the sponsor may submit a concurrent 510(k) notification and de novo petition. FDA will then review the 510(k) notification, issue the NSE (unless a predicate device has been classified through the de novo process in the interim), and then proceed directly to reviewing the classification petition.
The proposed PDS process has the potential to make the de novo pathway a more realistic option. It will presumably allow an early assessment of whether the product is likely suitable for the de novo pathway, and could shorten the overall review time currently associated with de novo classification.
A key question left unanswered by the Draft Guidance is whether FDA will be willing to designate a wider variety of devices as eligible for the de novo pathway. In the past, FDA has been quite limited in this regard. If the PDS process makes the de novo pathway more viable, we would urge FDA to allow more devices to take advantage of it than has been the case in the past. Interestingly, increased use of the de novo pathway also would move the FDA away from the 510(k) process and review for substantial equivalence, as critics have urged. One wonders whether FDA’s implementation of this Draft Guidance might be a baby step toward a new review process that ultimately could replace 510(k) clearance.