Strengthening the Clinical Trial Enterprise for Medical Devices: An FDA/CDRH Strategic Priority Update


The following was extracted from FDA Voice


Every day, millions of Americans rely on FDA approved or cleared medical devices to save, sustain, or improve the quality of their lives. The Center for Devices and Radiological Health (CDRH), is committed to patients having access to high – quality, safe, and effective medical devices, as quickly as possible. Innovation is key to both speed and excellence in that endeavor.


In general, clinical trial data are required in premarket submissions for the highest risk devices to demonstrate that they provide a reasonable assurance of safety and effectiveness. Therefore, the sooner those trials can safely begin, the sooner patients have access to potentially important, innovative technologies. As part of FDA’s 2014 – 2015 Strategic Priorities, CDRH committed to reducing the time and cost of regulatory and non – regulatory aspects of the U.S. clinical trial enterprise, while assuring the protection of human subjects and the generation of robust data.


In 2015, FDA continued to advance clinical trial programs with publication of a new draft guidance document related to FDA considers benefits and risks for Investigational Device Exemptions (IDEs) decisions. These decisions are tailored to the type and intent of the clinical study. FDA also issued a draft guidance that, when final, will encourage the use of adaptive designs for clinical trials and we are considering additional process improvements.


FDA also retrained the review staff on the practical challenges related to conducting a successful trial. As part of this training, more than 100 review staffers visited clinical trial sites to better understand the context and challenges of initiating and conducting clinical trials in the U.S.


Where has all this led? IDE review times, which had already improved in 2014, have continued to progress in 2015. For example:


From 2011 to 2014, the median number of days to full IDE approval decreased from 442 days to 101 days.

During 2015, the median number of days to full IDE approval has decreased to 30 days.


Additionally, full approval entails fewer review cycles. In 2011, only 15% of IDEs were approved within two review cycles. In 2015, 74% of IDEs were approved in two review cycles. This performance meets FDA’s strategic goals and, more importantly, means that important technologies have the potential to reach US patients sooner.


Early Feasibility Studies (EFS) are small clinical studies designed to gain early insights into an innovative technology during the development process before starting a larger clinical trial. EFS often are a critical step in device innovation, but they are frequently conducted in other countries rather than in the U.S. Device developers tend to conduct subsequent feasibility and pivotal clinical studies and then bring their products to market earlier in those countries, where they conducted an EFS to leverage clinicians who have gained experience with their technologies.


As part of our 2014 – 2015 Strategic Priority to Strengthen the Clinical Trials Enterprise, CDRH established a goal of increasing the number of EFS IDEs submitted to each review division in the Center. Interest in the EFS program has grown substantially, with a 50% increase in the number of EFS submissions during the first nine months of 2015, compared with the same period in 2013. In addition, six of our seven Office of Device Evaluation (ODE) review divisions reported an increase in the number of EFS submissions for 2015 compared with 2013. Recently, FDA developed a comprehensive educational module to help industry navigate the EFS process. FDA expects that this is just the beginning and we will continue to see more EFS conducted in the U.S.


To obtain more details regarding FDA’s performance for this important strategic priority, see Clinical Trial Performance Update – September 2015.



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