A pilot program on medical device early feasibility studies (EFS) with “commitments on timeframes and much more standardized approaches” will be launched under the Medical Device Innovation Consortium (MDIC) in the coming months, the US Food and Drug Administration’s (FDA) Center for Devices and Radiological Health (CDRH) Director Jeff Shuren said Wednesday at the 11th annual FDA-AdvaMed Medical Devices and Diagnostics Statistics conference.
As the device space becomes increasingly complex, EFS can serve as an aid to achieve time and cost savings
by gaining early clinical evaluations to guide any needed modifications to a product’s design before it is finalized.
Sponsors can submit an investigational device exemption (IDE) application for experimental devices to be evaluated through an EFS—typically conducted prior to the pivotal study phase.
Early insights may be crucial in the development of new devices as—in contrast with drugs—these are oftentimes subject to modifications on a near constant basis, Shuren noted.
The continued support for domestic EFS speaks to not only the push for extending the least burdensome principles of the FD&C Act
across the total product lifecycle, but also CDRH’s vision to have devices available to US patients first in the world. Historically, device firms have conducted EFS overseas to avoid navigating the relatively harsh regulatory standards in the US.
From the launch of CDRH’s EFS pilot program for IDEs
in November 2011 to the 2013 release of the FDA guidance
promoting its use, the changed policies and processes in this area to bring back these studies to the US has helped spur innovation, according to Shuren. As a result, the center has seen a 50% increase in the number of IDE submissions for these studies on an annual basis since 2015, totaling more than 120 as of 2017, with upwards of 50 companies participating.
However, there is still "a lot more work underway to look at non-regulatory issues” associated with EFS, such as the timelines for Institutional Review Board reviews, Shuren said.
The pilot coming out of MDIC is intended to address remaining barriers facing study sponsors with initiating EFS and enrolling study subjects. MDIC is using performance metrics to identify and develop the “tools and best practices for EFS sponsors and clinical researchers alike” with the goal of driving “overall EFS efficiency and support continuous assessment of EFS efficiency and effectiveness for US patients,” according to its website
Shuren added that “a number of healthcare institutions” will be involved to better understand how to obtain robust evidence for greater efficiency around review processes and decision-making.
AdvaMed spokesperson Mark Brager told Focus
the trade association and its members support the FDA/MDIC pilot on EFS, with recommendations on ways to improve the process including the “development of a core team of EFS staff with expertise and understanding of risk/benefit calculations with participation from each of the review divisions to provide a consistent approach...and continuity of product review.”
Another improvement area relates to “implementing an interactive process between FDA and the sponsor, including in-person meetings and teleconferences with communication of any major concerns FDA may have early in the interactive process,” Brager said.
The currently available process for early interactions on FDA-sponsor reviews of IDEs for EFS is the one use for pre-submissions, as described in the 2013 final guidance.
“FDA should focus on a development of a collaborative, predictable process that focuses on essential requirements for patient safety,” Braeger added.