Holding Early-Stage Meetings
Once a company decides that a pre-IDE meeting is appropriate, it needs to determine when to hold the meeting. Some companies like to have meetings at an early stage, so they can introduce FDA to their technology and aspirations. In general, these meetings are not terribly productive. They do allow the company to meet some of the reviewers, and begin educating them on some of the novel features of the technology. FDA staffers are invariably polite and curious, and ask some good, probing questions.
Early meetings typically do not lend themselves to gaining targeted FDA feedback. They are more didactic, and less regulatory focused. Thus, while these meetings allow companies to put faces with names and familiarize FDA with their product and technology, the sponsor usually receives little information that will facilitate the clearance or approval process.
A company is better served if its pre-IDE meeting provides a forum for gaining feedback from FDA on well-defined questions. This requires there to be some crystallization of the company’s plans. Going into a meeting and asking FDA an open-ended question about what to do is a sure-fire way of courting trouble. For example, the company should never ask FDA what kind of clinical study to conduct; the company should seek FDA’s comments on the company’s own proposal. Therefore, a company should not ask to meet until it is prepared to provide to FDA an intended use (See GEN, November 15, 2008 “Adroit Crafting of Intended Use Critical”), a study population, a protocol, plans for preclinical testing, and a statistical plan.
Companies may also propose a regulatory pathway. There can be huge time and cost advantages in 510(k) review or de novo approval instead of a PMA (See GEN, August 2008, “Regulatory Pathways for Molecular Dx”). During the pre-IDE meeting, the FDA may indicate receptiveness toward a 510(k) or the de novo route. Other times, FDA will unequivocally state that a PMA is needed. This news may be unwelcome, but receiving it earlier helps planning and may provide an opportunity to revise the intended use and clinical protocol to restore the possibility of a 510(k). Other times, FDA will say that the classification decision must await the results of the study.