The recent FDA strategic priority to increase the number of early feasibility studies (EFS) conducted in the U.S. resulted in dramatic increases in EFS investigational device exemption (IDE) approvals. However, opportunities remain to improve the process and submission quality.
One of the big trends facing the FDA in 2016 is the continuing increase of EFS IDE submissions in the U.S. and how approval rates can improve. EFS is a type of clinical study that involves a small number of patients to investigate a device that may be early in the development process and for which the device design may not yet be finalized. EFS may be used to establish a “proof of concept” for a novel technology or a new clinical use for an existing device. In addition, EFS may provide initial insights into a device’s clinical use and safety.
Due to often burdensome IDE requirements imposed by FDA for these type of studies, early studies were commonly conducted outside of the U.S. In recognition of this shortfall, FDA focused efforts on developing an EFS program as part of their 2014-2015 Strategic Priority to “Strengthen the Clinical Trials Enterprise”. Based on published reports, the Center for Devices and Radiological Health (CDRH) saw an overall 50% increase in EFS IDEs submitted during the first 9 months of FY 2015 compared to FY 2013, and a 100% increase in EFS IDE approvals. FDA also reported 6 out of the 7 review divisions in CDRH’s Office of Device Evaluation (ODE) saw an increase in the number of EFS submissions received in FY 2015 compared to FY 2013.
In 2013, FDA published a final guidance on IDEs for EFS. One key aspect of the guidance is focused on FDA’s flexibility in allowing less nonclinical data to support approval for EFS IDEs compared to traditional feasibility and pivotal studies. Another significant feature of the guidance is communication of new FDA policy to enable more timely device and protocol iterations during patient enrollment in the EFS.
It is reasonable for medical device manufacturers to expect FDA to continue improving the EFS submission process, which may continue to increase the number of studies conducted in the U.S. As the number of EFS submissions increase, FDA review divisions continue to gain additional experience with the EFS program. Specifically, each division has EFS representative members in place to aid the review teams in agreeing on the type and amount of supporting data needed to support the EFS IDE. The EFS guidance, as well as the Early Access Program (EAP), is expected to be revised to capture lessons learned, and to provide additional guidance to the industry on the process.
Another aspect of FDA’s focus may be on submission quality. In the report referenced above, it is not stated how many EFS IDEs are converted to Pre-Submissions during the review, which may be one route for FDA to address significant quality issues. Webinars presented by FDA’s Clinical Trials Program staff have highlighted how many IDE submissions fail to provide basic information needed for FDA’s review. Although it is not anticipated for FDA to institute a formal Refuse-to-Accept policy for IDEs due to their short review time, it is anticipated FDA will focus on other ways to try to improve the quality of IDE submissions.
As the FDA continues to improve the EFS submission process, it is important to ensure that industry experience is shared with the FDA’s EFS Program staff. In the coming months NAMSA will be conducting a survey to gain insight from medical device manufacturers. Results are intended to be shared with the agency and published.
|Kristy Katzenmeyer-Pleuss, Ph.D.
Kristy Katzenmeyer-Pleuss, Ph.D.
Kristy Katzenmeyer-Pleuss is a former FDA medical device reviewer and currently a Senior Medical Research Manager in the Regulatory Department at NAMSA. She holds a Ph.D. in Bioengineering from the University of Washington and a B.S. in Chemical Engineering from the University of Wisconsin-Madison. While at FDA, Dr. Katzenmeyer-Pleuss was a member of several working groups related to Early Feasibility Studies. Her experience includes premarket submissions for a variety of device types, including general surgical, dermatologic, cardiovascular, peripheral venous, oncologic, orthopedic, and aesthetic devices.
Principal Medical Research Manager
Angela Mallery EdD, has over 25 years of experience working in device regulatory affairs in small, medium and large sized companies. Angela is a project manager and regulatory consultant for NAMSA on worldwide device regulatory registrations, including cardiac and peripheral devices, tissue products and urology devices. She also holds an adjunct faculty position at St. Cloud State University, teaching in the regulatory program.