On Thursday, September 20, the Food and Drug Law Institute (“FDLI”) and the Drug Information Association (“DIA”) co-sponsored a program titled “Unwrapping FDA’s UFA Package: What’s Inside the Statute – What’s Next?” The program discussed many aspects of the recently passed Food and Drug Administration Safety and Innovation Act (“FDASIA”) (see our summary here), from user fees to substantive changes in the pre- and post-market regulation of drugs and devices.
Some highlights of the device sessions include the following:
Benefit-Risk Determinations. Though FDASIA does not explicitly require FDA to make benefit-risk determinations in the premarket review of medical devices, CDRH representatives indicated that they intend to do so. In fact, one representative stated that benefit-risk and increased user participation in the review process are two of the most exciting FDASIA provisions, and that it is important to look not only at clinical data, but also at patient data about the willingness to tolerate certain risks. She stated that CDRH is already conducting a pilot study in which patients are being surveyed about the risks they are willing to accept for surgical procedures to address obesity. She also noted that CDRH will be initiating a Patient Preference Project with a meeting in the spring about how best to gather the patient perspective in device reviews.
De Novo Process. As expected, FDA and industry are both pleased with the changes FDASIA made to the de novo process. One CDRH representative noted that, while the changes provide an opportunity to be more efficient with de novo devices, there are no user fees for de novo applications. Thus, it will be important to CDRH to examine whether devices actually qualify for the de novo process and do not have predicates to which they could claim substantial equivalence. Whether companies would actually seek de novo status to avoid a 510(k) user fee is somewhat doubtful.
Appeals. FDASIA implemented timeframes for appealing “significant decisions” but did not specify what actions constitute significant decisions. A CDRH representative at the meeting indicated that CDRH will be issuing a guidance document describing the activities that it considers to be “significant decisions.” CDRH indicated that NSE letters, not approvable decisions, and IDE denials will be among the significant decisions appealable within the FDASIA-specified timeframes. CDRH stated that letters such as requests for additional information will likely not be considered “significant decisions.” This means that, while an AI request could continue to be appealed under 21 C.F.R. § 10.75, the process will not have to abide by the timeframes in the new law.
Another issue discussed regarding appeals is when a requester would receive the summary of the decision as mandated by FDASIA. Since FDASIA requires the sponsor to file an appeal within 30 days of the “significant decision,” it will be important to receive the summary information as soon as possible to incorporate into the appeal. Based on statements at the meeting, CDRH has not yet determined when it will provide the summary information in response to a request. It stated that it will “probably” be provided in time to use in the appeal, but appeals historically have been based on the letter itself, and CDRH would expect the same to be true moving forward. Unfortunately, the denial letters often do not provide much useful information describing the reason for the denial, so sponsors will undoubtedly be looking to receive that summary information to support their appeal and better understand the grounds for the adverse decision.
CDRH stated a concern with the new timeframes, namely, that they will encourage sponsors to appeal decisions rather than working them out informally with the review division. This concern is unlikely to materialize, since most sponsors would rather resolve issues informally than incur the delay and costs associated with an appeal.
Device Modifications. A moderator asked CDRH about the practical effect of the 2011 draft guidance on when to submit a new 510(k) for modifications to a cleared device. He pointed out that, just because Congress told FDA to do away with that draft guidance and use the 1997 guidance, the 2011 draft gives insight into FDA’s thinking about these issues. See our earlier blog post on the 2011 draft guidance here. In response, CDRH said that, from an agency perspective, the 1997 guidance is still in effect, and that if FDA takes action, it will be based on the 1997 guidance.
Reclassification. The reclassification provision in FDASIA required reclassification through order, rather than regulation; this change was intended to expedite reclassifications. At the same time, FDASIA said all reclassifications need to go before a panel. CDRH’s perspective is that, as a result, it could now take longer to downclassify certain devices. The industry representative on the panel acknowledged that in urging Congress to require a panel prior to reclassification, industry was concerned about upclassification, and perhaps had not considered the impact on downclassifying devices.
CDRH also seemed unsure about how the new law will affect the progress made to date on reclassifying some of the Class III devices for which FDA has not yet called for PMAs. CDRH indicated that progress would likely be stalled, and panels would need to be called. It is not clear whether the law was intended to have this type of retroactive effect.
IDEs. CDRH has already made certain changes to its IDE template to align with FDASIA’s requirement not to deny IDEs just because CDRH believes they may not support a clearance or approval. CDRH stated that it wants to incentivize manufacturers to “design the right study,” but it has not yet decided what that incentive will be. It is contemplating two separate paths, one for sponsors who want to start a study even if it is not ideal from FDA’s perspective, and one for sponsors who will work with FDA to design a study that FDA will “endorse.” This may involve the creation of a pre-decisional IDE pathway, different from a pre-submission meeting because the pre-decisional meeting will look at data, whereas pre-submission meetings are intended to provide feedback on product development. Presumably CDRH will be issuing guidance on its new approach to IDEs and clinical trials in the reasonably near future.