Making the Most of Pre-IDE Meetings

March 1, 2009

In order to sell diagnostic devices in the U.S., in vitro diagnostic (IVD) manufacturers need to get marketing authorization from FDA. That raises an obvious question: How does a company know what data to submit and which regulatory pathway to use?

One way is to ask FDA for guidance. The Office of In Vitro Diagnostics has been receptive to meeting with companies and discussing clinical study plans and proposed regulatory pathway. These meetings are accomplished through the pre-IDE (investigational device exemption) process. (The term pre-IDE is something of a misnomer, because virtually all of these meetings occur without the company submitting an IDE.)

Should IVD companies request a pre-IDE meeting? If so, when? How can they get the most out of the meeting? This article will discuss these and other questions.

Additional information available here.