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Regulatory News
5 March 2012
by Alexander Gaffney, RAC

Moving Ahead of Pace, FDA Extends IDE Pilot Project

The US Food and Drug Administration (FDA) announced 5 March that it is both closing the nominating process for its Early Feasibility Study Investigational Device Exemption (IDE) Applications pilot program and extending the length of the program for an additional year.

The program was originally slated to terminate on 8 May 2012. It will now end on 8 May 2013 for the nine enrolled applicants.

The program "allow[s] the submission of nominations from sponsors of innovative device technologies to participate in a pilot program for early feasibility study IDE applications," according to FDA.

The pilot program was launched in conjunction with a draft guidance entitled "Investigational Device Exemptions (IDE) for Early Feasibility Medical Device Clinical Studies, Including Certain First in Human (FIH) Studies."


Read more:

FDA - Pilot Program for Early Feasibility Study Investigational Device Exemption Applications: Termination of Acceptance of Nominations and Extending Duration of Program

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