A CDRH Priority: Clinical Trials in the U.S.

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

At the Center for Devices and Radiological Health (CDRH), clinical trials are the foundation for our decisions to approve the most important medical devices—products that have the potential to save or sustain life, but that also present the greatest risk to patients.

Owen Faris

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

Over the past year, we saw several exciting new medical devices reach U.S. patients, including devices to treat heart disease and diabetes and diagnose cancer. Just last week, we approved a new device to treat obesity. None of these products would have come to market without clinical trials.

CDRH is committed to improving U.S. patient access to new devices by strengthening and streamlining the process of testing complex medical devices so that their clinical trials are conducted in the U.S. in a safe, efficient and cost-effective manner. In fact, this is so important for us that we made it one of our three 2014-2015 Center Strategic Priorities, along with striking the right balance between premarket and postmarket data collection and improving our customer service. Please visit our website for an update on our Strategic Priorities.

Innovative medical products begin with clinical trials – and before a clinical trial of a significant risk device begins in the U.S., a researcher, among other things, must apply for and receive FDA’s approval through the Investigational Device Exemption (IDE) process.  The FDA reviews IDE applications to determine whether the sponsor has provided enough information to be sure that the study does not present an unreasonable risk to its participants. FDA takes into account the qualifications of the clinical investigators, information about the device, the design of the clinical investigation, the condition for which the device is to be investigated, and the health status of the participating patients.

Jeffrey Shuren

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

FDA reviews an IDE submission within 30 days, but the review often results in questions which the study sponsor needs to answer, or changes that are needed before the study can be approved. Just a few years ago, it was therefore not uncommon for a year or more to pass before FDA could grant approval to a medical device developer to begin the trial. This type of delay was one factor that led developers to seek approval in other countries.

Over the past year, CDRH has taken a number of actions to expedite the safe initiation of clinical trials in the U.S., and we believe these policies will result in conducting clinical studies in the U.S. earlier in the device development process than was the case in the past.

Our improvements started with establishing a formal Clinical Trials Program within the Office of Device Evaluation. This program provides consistency in decision-making and encourages more interaction between FDA and the device industry during the IDE process. We also provided extensive training to CDRH review staff and the device industry. In addition, we issued numerous guidance documents, including one explaining IDE Decisions and one introducing CDRH’s new Early Feasibility Study program.

We’re excited to report that these changes have greatly shortened the time for an IDE to reach approval, so that a clinical trial can begin. From 2011 to 2014, the median number of days to full IDE approval has decreased from 442 to only 101. This cuts the time it takes to bring a new medical device to market by nearly a full year.

To learn more about CDRH’s clinical trials program, please join us for a webinar on January 22, 2105, where we will discuss the implementation of the IDE processes, our 2015 performance goals, early feasibility studies and our future plans. More information, including how to attend, is on the CDRH Webinar webpage.

The FDA is charged with the enormous task of protecting and promoting the health of the American public. To do this, we must ensure that the medical products on which Americans rely every day have been rigorously tested and are safe and effective. We are committed to making U.S. patients the first in the world to have access to safe and effective medical devices. And we’ve taken the first step to that, by helping ensure that clinical trials take place here, in the U.S.

Owen Faris, Ph.D., is Clinical Trials Director (acting), Office of Device Evaluation in 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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