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

By: Owen Faris, Ph.D., and Jeffrey Shuren, M.D., J.D.

Every day, millions of Americans rely on FDA approved or cleared medical devices to save, sustain, or improve the quality of their lives. At the Center for Devices and Radiological Health (CDRH), we are 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. And as we discussed in our blog earlier this year, clinical trials are a key component to the device innovation process.

Owen Faris

Owen Faris, Ph.D., Clinical Trials Director (acting), Office of Device Evaluation in FDA’s
Center for Devices and Radiological Health

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, and the sooner those trials can safely begin, the sooner patients have access to potentially important, innovative technologies. As part of our 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In 2015, we have continued to advance our clinical trials program with publication of a new draft guidance document related to how we consider benefits and risks for Investigational Device Exemptions (IDEs) decisions. These decisions are tailored to the type and intent of the clinical study. We’ve also issued a draft guidance that, when final, will encourage the use of adaptive designs for clinical trials and we are considering additional process improvements.

Jeffrey Shuren

Jeffrey Shuren, M.D., J.D., Director of FDA’s Center for Devices and Radiological Health

We’ve also trained our review staff on the practical challenges related to conducting a successful trial. As part of this training, more than 100 review staffers visited sponsors of clinical trials 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 our 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, we developed a comprehensive educational module to help industry navigate the EFS process. We expect that this is just the beginning and we will continue to see more EFS conducted in the U.S.

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

We are committed to making U.S. patients the first in the world to have access to high-quality, safe and effective medical devices. We believe these results are clear evidence that we are moving the right direction, helping to ensure that robust and efficient clinical trials that provide appropriate human subject protections take place here in the U.S.

Owen Faris, Ph.D., is Clinical Trials Director (acting), Office of Device Evaluation at FDA’s Center for Devices and Radiological Health

Jeffrey Shuren, M.D., J.D., is Director of FDA’s Center for Devices and Radiological Health

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