On February 5, 2014, CDRH released its 2014-2015 Strategic Priorities, in which it stated that the most important areas of focus over the next two years will be to “strengthen the clinical trials enterprise,” “strike the right balance between premarket and postmarket data collection,” and “provide excellent customer service.”
Clinical Trials Enterprise
The key component of this priority is to find ways to encourage sponsors of clinical trials to conduct those trials in the United States rather than overseas and to do so early in the device development process. CDRH aims to achieve this goal by improving the efficiency, consistency, and predictability of the IDE process to reduce the time and number of cycles needed to obtain IDE approval, and to increase the number of early feasibility/first-in-human IDE studies submitted to FDA and conducted in the U.S.
CDRH has already taken steps over the last two years to improve the IDE and clinical trial processes. For example, in 2012, FDA issued a guidance document that describes the factors it considers in making premarket risk/benefit determinations, including patient perspective on risks and the willingness to accept increased risk for certain conditions. To build on this, CDRH states that as part of its strategic priorities it will “formalize the incorporation of [its] benefit-risk framework, including patient-specific factors such as tolerance for risk and perspective on benefit, into the IDE process.” Such formalization will help sponsors better understand the various factors that might influence whether and how quickly an IDE might be approved, which could possibly, in turn, positively influence a decision about conducting the study in the United States. CDRH should also address the amount of data needed to initiate a study, which can, in and of itself, be an insurmountable burden.
Premarket v. Postmarket Data Collection
The question of the appropriate amount of data to collect premarket versus postmarket generally applies to devices approved through the PMA process, and is an area that industry and FDA have long debated. Industry’s position has been that FDA may request data that is too extensive to gather premarket, and will delay entry of potentially life-saving or highly beneficial devices to the U.S. market. FDA has argued that without sufficient premarket data, it could be allowing products onto the market that have not demonstrated reasonable assurance of safety and effectiveness.
The strategic priorities indicate that CDRH recognizes that burdensome data requirements can adversely affect when patients in the U.S. will have access to a device, and notes that it is “critical” for CDRH to “strike the right balance between premarket and postmarket data collection.” The “balance” is between improving patient access to devices while assuring postmarket data collection will occur in a timely fashion, thereby enabling a more rapid evaluation of safety of the device in use.
This strategic priority may be the first time CDRH has specifically put forth a plan for determining the devices for which data requirements may be shifted from pre to postmarket. This plan involves reviewing all device types subject to PMA approval “to determine whether or not to shift some premarket data requirements to the postmarket setting or to pursue down classification, and communicate those decisions to the public.” Certainly there is no guarantee that CDRH will find that a data shift or down classification is appropriate for any PMA device, or will do so in a meaningful time frame (another FDA Center just responded to a Citizen Petition almost 39 years after it was submitted) but it is encouraging to see CDRH recognizing this as a possibility and setting forth timeframes within which such a review should occur. As part of the review, CDRH will seek public input on when data shifting is appropriate. Hopefully, FDA and industry can work together to reach agreement with respect to when it is appropriate to shift data requirements to the postmarket setting, allowing the public earlier access to medical devices while continuing to assure the safety and effectiveness of those devices.
Provide Excellent Customer Service
This is perhaps the most interesting and unexpected of the strategic priorities. Industry has long complained about the unresponsiveness of CDRH to its inquiries and the lack of transparency and consistency with respect to its decision-making. Perhaps this priority is a sign that CDRH is finally considering how its interactions with industry impact whether manufacturers choose to pursue clearance or approval in the U.S.
To provide excellent customer service, CDRH will be implementing “customer service standards,” which include active listening, problem solving, seeking out the ideas of others, explaining the reason for CDRH’s decisions and requests for information, learning from its mistakes, and “doing our best.” These are all sufficiently vague (particularly “doing our best”) that is not clear how the “customers” (industry and other stakeholders) will determine whether an adequate level of customer service has been obtained. The strategic priorities indicate that there will be a survey tool in emails and on the website, and a CDRH program will be established to monitor and address feedback and improve quality and performance. It is not clear how CDRH will ensure that it obtains feedback from a majority of “customers” or how those customers are intended to rank issues like whether CDRH did its best, or what CDRH will do with this feedback. It is encouraging to see CDRH acknowledging that its interactions with stakeholders must be improved, but it is not clear from the information in the strategic priorities precisely how that will be accomplished or measured.
In sum, CDRH’s strategic priorities seem to constitute positive steps. Whether they will result in regulatory improvements or represent aspirations that will go unfulfilled remains to be seen.