Skip Page Banner  
HEALTH CARE
BLOG

 

Friday, April 19, 2013

FDA To Try Again With Investigational Devices

by Nathaniel Weixel

RSS

Jeff Shuren, head of FDA’s medical devices division, hinted during a conference in DC earlier this week that the agency will be re-issuing a draft guidance on investigational device exemption (IDE) submissions. Shuren said FDA wants to make it more attractive for manufacturers to initiate clinical trials inside the U.S. instead of overseas.

The IDE process allows clinical investigators to initiate a study on a significant risk device. The guidance discussed when the agency might allow patients to enroll in a study while issues are still being resolved ,and also discussed when FDA might allow studies to begin with a smaller group of subjects while companies gather additional data, prior to the larger general enrollment.

The original draft guidance was issued in 2011, and was part of FDA’s attempts to streamline the various aspects of the device approval process. The guidance was intended to speed up the time for an investigational device to reach the market, but when it was published it was met with plenty of backlash from industry. So it seems that the agency is giving it another try. Shuren wouldn't put a timeline on when the replacement guidance would be out, and wouldn't say what would be included in it, only that there would be some new items. We’ll find out more once the new draft is actually out.
Subscription RequiredAll BNA publications are subscription-based and require an account. If you are a subscriber to the BNA publication and signed-in, you will automatically have access to the story. If you are not a subscriber, you will need to sign-up for a trial subscription.

You must Sign In or Register to post a comment.

Comments (0)