The number of investigational device exemptions submitted under CDRH’s Early Feasibility Study Program has more than doubled, with 57 submitted in FY 2017 up from 26 when the agency issued EFS guidance in 2013.
Agency officials said 75 percent of IDEs submitted over the last two years have received timely FDA approval within the 30-day review cycle.
Approximately half of EFS IDEs are submitted by small medical device manufacturers as the program is intended for agency staff to aid study sponsors, especially those with limited financial resources, during early clinical evaluations of new medical technologies.
“An important lesson learned from the EFS Program so far is that the enhanced opportunities for collaboration between the sponsor and FDA’s review team are crucial for success,” said Owen Faris and Andrew Farb at CDRH’s the Office of Device Evaluation, and Maureen Dreher at CDRH’s Office of Science & Engineering Laboratories in a blog post. — Ana Mulero