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A CDRH Priority: Clinical Trials in the United States

Striving to get U.S. patients fast access to safe and effective medical devices

Published: Monday, February 9, 2015 - 16:46

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 also present the greatest risk to patients.

During 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. In January 2015 we approved a new device to treat obesity. None of these products would have come to market without clinical trials.

The 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 United States in a safe, efficient, and cost-effective manner. In fact, this is so important that we made it one of our three 2014–2015 strategic priorities, along with striking the right balance between pre-market and post-market data collection and improving our customer service. 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 United States, a researcher, among other things, must apply for and receive the 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. The 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.

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 wasn’t uncommon for a year or more to pass before the 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.

In 2014, the CDRH took a number of actions to expedite the safe initiation of clinical trials in the United States. We believe these policies will result in conducting clinical studies in the United States earlier in the device development process.

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 the FDA and the medical device industry during the IDE process. We also provided extensive training to CDRH review staff and the medical device industry. In addition, we issued numerous guidance documents, including one explaining IDE decisions and one introducing CDRH’s 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 view our on-demand webinar (initially held on January 22, 2015), in which we discussed the implementation of the IDE processes, our 2015 performance goals, early feasibility studies, and our future plans. Information on how to access the on-demand version of the webinar can be found on the CDRH webinar web page.

The FDA is charged with the enormous task of protecting and promoting the health of the U.S. public. To do this, we must ensure that the medical products on which U.S. citizens 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 by helping ensure that clinical trials take place here, in the United States.

First published Jan. 21, 2015, on FDAVoice.

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About The Authors

Owen Faris’s picture

Owen Faris

Owen Faris is the acting clinical trials director of the Office of Device Evaluation in the FDA’s Center for Devices and Radiological Health.

Jeffrey Shuren’s picture

Jeffrey Shuren

Jeffrey Shuren is the director of the Food and Drug Administration’s (FDA) Center for Devices and Radiological Health. Shuren has held various policy and planning positions within FDA from 1998 to 2009, including acting deputy commissioner for policy, planning, and budget; associate commissioner for policy and planning; special counsel to the principal deputy commissioner; assistant commissioner for policy; and medical officer in the Office of Policy. Shuren received his bachelor’s and doctor of medicine degrees in medical education from Northwestern University under its Honors Program.