NEWS TRENDS

It's common for firms pursuing an investigational device exemption (IDE) to have a pre-IDE meeting with FDA. What may not be commonly known, however, is that these meetings are not open-ended and not without time limit. To ensure a successful pre-IDE meeting, a firm must be extremely well prepared, experts told those at the RAPS annual meeting in October 2006.

Nicole Landreville, director of quality and regulatory affairs at Excel Tech Ltd. (Oakville, ON, Canada), said that a firm must submit an agenda and five to seven questions for FDA in advance. No revisions are allowed once FDA receives the submission. A meeting won't be scheduled without a specific agenda that includes a realistic estimate of how much time each topic should take.

That means that firms must choose their questions carefully. “You must ask about size and end points” of a clinical trial, Landreville noted. “And you should prepare some ‘oh, by the way' questions too, in case you have time left,” she added.

Elisa Harvey, senior regulatory consultant for CardioMed Device Consultants LLC (Gambrills, MD), said it's important that the questions be focused: “Ask whether the proposed primary end points are appropriate to support the indication for the intended patient population rather than whether the study is OK.”

Knowledge of clinical and statistical issues is essential, and a firm's team should have someone at the meeting who can discuss them, Landreville said.

There are several points where it makes sense to ask for a pre-IDE meeting, said Harvey. Those times include prior to conducting proof-of-concept animal studies, during the preclinical phase, and prior to expanding trials to the pivotal phase.

FDA particularly encourages pre-IDE meetings during the preclinical phase, she said. That is often the best time for FDA feedback on a bench testing plan, animal study protocols, feasibility study protocols, and the appropriate regulatory pathway.

Harvey said that firms also need to be aware of what pre-IDE meetings are and, likewise, what they are not. They are a tool to provide informational feedback on test plans and related issues. They are not tools for negotiation or a review of data, nor are they legally binding or a method for dispute resolution.

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