Getting IDE Approval Is Now Quicker than Ever

Marie Thibault

CDRH is getting faster on metrics that matter to medical device manufacturers, like shorter device review times. Now, the center has become even speedier on another measure—the time it takes to get an Investigational Device Exemption (IDE) approved.

Device makers and trial sponsors for a high-risk medical device need to get IDE approval from FDA for a clinical trial. This used to be a common cause of delays in the device development process. As CDRH director Jeffrey Shuren, and Owen Faris, acting clinical trials director in CDRH's Office of Device Evaluation, wrote in a January FDA Voice blog post, "Just a few years ago, it was therefore not uncommon for a year or more to pass before FDA could grant approval to a medical device developer to begin the trial. This type of delay was one factor that led developers to seek approval in other countries."

Now, it looks like those days are behind CDRH. According to the center's summarized tally of its performance against its strategic priority to "strengthen the clinical trial enterprise," the median number of days it takes to secure full IDE study approval is just 30 days. That's a whopping decrease from the median 442 days in fiscal year 2011 and a dramatic reduction even from the median 101 days in fiscal year 2014. That achievement is exactly in line with CDRH's goal of reaching a 30-day median time by June 30, 2015.

In a September 24 FDA Voice blog post, Shuren and Faris explain that this speed is the result of a few actions, including draft guidances on benefits and risks for IDE decisions and adaptive trial design, as well as real-world training for IDE review staff.

Hand-in-hand with faster review times is how many review cycles it takes for IDE studies to gain approval. It makes sense that CDRH has made strides here too, with 73.5% of IDE studies fully approved within two review cycles in fiscal year 2015, as opposed to 63.0% in fiscal year 2014 and just 14.8% in fiscal year 2011. This is meaningful, Shuren and Faris write, because it "means that important technologies have the potential to reach US patients sooner."

In addition, the center has been working on upping the number of early feasibility and first-in-man IDE studies submitted and approved. Here too, CDRH is hitting its goals. The number of such submissions increased 50% between fiscal year 2013 and the first 9 months of fiscal year 2015 and during this time, the number of early feasibility studies approved doubled.

Marie Thibault is the associate editor at MD+DI. Reach her at [email protected] and on Twitter @medtechmarie.  

[Image courtesy of SALVATORE VUONO/FREEDIGITALPHOTOS.NET]