FDA Issues New Draft Guidance on IDEs

FDA released new guidance today to address investigational medical device studies in humans.

 The draft guidance, "FDA Decisions for Investigational Device Exemption (IDE) Clinical Investigations" is designed to clarify the FDA's process for approving clinical trials of medical devices.  It includes information regarding:

• When the FDA might allow patients to enroll in a study while issues are resolved, an approach called "approval with conditions."
• When the FDA might allow studies to begin with a smaller group of subjects while companies gather additional data, prior to the larger general enrollment, an approach called "staged approval."

This has been a long-awaited draft guidance, and MDMA is closely examining the details.  We will discuss this guidance and other issues on our next Working Group Call scheduled for Tuesday, December 13th at 2 pm EST.

 To read a copy of this guidance, click here.