The three priorities include strengthening the clinical trials enterprise, finding a balance between premarket and postmarket data collection and providing excellent customer service. The priorities and goals have been developed with the expectation that developers will choose the U.S. as the first country in which to launch their technologies. Also, improved customer service will strengthen CDRH’s interactions with stakeholders and colleagues and ultimately, support better regulatory outcomes.
What do these priorities entail? How will CDRH achieve them?
Strengthen the Clinical Trial Enterprise
CDRH plans to streamline the clinical trial process, making it more efficient and cost-effective for manufacturers. Its two goals include: 1) Improve efficiency, consistency and predictability of the Investigational Device Exemption (IDE) process in order to reduce the time and number of cycles needed to reach IDE full approval and 2) Increase the number of early feasibility/first-in-human IDE studies that are submitted and conducted.
CDRH pointed out that recent programs, including the FDA Decisions for Investigational Device Exemption Clinical Investigations, have led to some improvement. IDE submissions that received an approval decision to authorize study initiation within two IDE cycles increased from 46 percent in FY11 to 77 percent in FY13, and the medical time to full study approval reduced from 435 days to 174 days.
To achieve these goals, CDRH has outlined steps that include teleconferences with manufacturers that receive disapproved IDEs and establishment of a premarket clinical trials program within the Office of Device Evaluation.
Strike the Right Balance Between Premarket and Postmarket Data Collection
The goal outlined by CDRH is to assure the appropriate balance between premarket and postmarket data requirements to facilitate and expedite the development and review of medical devices, particularly high-risk devices. These efforts can be further supported through a National Medical Device Postmarket Surveillance System and the advancement of international harmonization surrounding the topic, including initiatives such as the International Medical Device Regulators Forum.
To achieve this goal, CDRH plans to review 100 percent of the device types subjected to PMAs on the market to determine whether or not some premarket data requirements should shift to postmarket collection. It will also seek public comment on a framework for when it’s appropriate to move the data collection from the premarket to postmarket setting.
Provide Excellent Customer Service
CDRH proclaims that its third focus—excellent customer service—can encourage device manufacturers to choose the U.S. as the first country in which they bring their product to market, while maintaining regulatory obligations. Its target is to achieve 70 percent customer satisfaction by December 31, 2014 and move the bar higher to 90 percent satisfaction by December 31, 2015.
To accomplish this goal, CDRH will implement customer service standards and use survey tools.
More on CDRH’s priorities and the metrics it has set can be found by clicking here.