Regulatory Focus™ > News Articles > Program Intended to Clear Path for Easier Medical Device Studies Kept Alive

Program Intended to Clear Path for Easier Medical Device Studies Kept Alive

Posted 25 April 2013 | By Alexander Gaffney, RAC 

The US Food and Drug Administration (FDA) has announced the extension of a pilot program first announced in November 2011 that aims to facilitate early feasibility studies for experimental medical devices.

Background

The 2011 announcement by FDA explained that the agency "intends to facilitate early feasibility studies of medical devices, using appropriate risk mitigation strategies, under the investigational device exemptions (IDE) requirements."

IDE applications are used by device sponsors much in the way that an investigational new drug (IND) applications is-to legally circumvent federal law that would otherwise prevent the a device from being entered into interstate commerce. In more practical terms, the applications effectively mark FDA's approval for the start of clinical trials, which for devices means early-stage trials to test a device's feasibility.

Explains FDA: "Early feasibility studies allow for limited early clinical evaluations of devices to provide proof of principle and initial clinical safety data before the device design is finalized."

Unlike pharmaceutical products, medical devices are subject to many iterative modifications during these early-stage tests, allowing device makers to work through design challenges that could affect the device's safety or effectiveness. Drug products are largely limited to changes in dose, but the active pharmaceutical ingredient itself does not stand to change during clinical testing.

So what's the benefit of doing a feasibility study as opposed to nonclinical testing? FDA explains that in some cases it's just not possible or appropriate to use nonclinical testing because they aren't able to advance the development process.

"As with all clinical studies, initiation of an early feasibility study must be justified by an appropriate risk-benefit analysis and adequate human subject protection measures," FDA added.

Kept Going-Again

FDA's broader goal, it has said, is to eventually expedite this process for those involved-something industry group AdvaMed has said it welcomes, likely reflecting the view of industry as a whole. And after the 2011 release of its draft guidance document on the subject detailing how it believes the process should work, regulators announced the start of a pilot program intended to allow some device manufacturers to try it out.

The pilot project, formally known as the Early Feasibility Study IDE Pilot Program, has already been extended once in March 2012, with FDA indicating that the original termination date of 8 May 2012 was insufficient.

The 23 April 2013 notice FDA published in the Federal Register indicates that the program will get yet another one-year extension, indicating either that the program is either wildly successful or still struggling to come to conclusions.

FDA's notice confirms that nine sponsors were enrolled into the program, and that all nine have remained in the program since December 2011.


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