FDA will want the meeting materials long before the meeting. Sixty days or more is preferable, but FDA will often accept materials 30 days in advance. Thus, companies need to have a well-developed meeting and regulatory plan in advance of the meeting. The sponsor should also plan on submitting its meeting presentation in advance even though the document may be finalized only hours before the meeting.
As is the case for all FDA meetings, companies need to prepare. When rehearsing presentations, companies should not neglect practicing how to respond to FDA’s questions. Companies should expect to be challenged. It is therefore important not just to fine-tune the planned remarks, but to work on the responses to the foreseeable probing questions. Having an outsider or two ask questions during a practice session can help the company get ready for the difficult questions it is likely to face. It can also help the presenters gain experience in thinking on their feet and responding to questions they had not anticipated. Companies also need to consider who should attend the meeting. They will want to have sufficient personnel to address various issues, e.g., clinical, statistical, legal, and regulatory, without appearing in overwhelming numbers.
Companies need to have a realistic understanding of what can be accomplished at a pre-IDE meeting. They will not receive any binding assurances from FDA. The meeting may proceed smoothly, FDA may raise no objections, the meeting minutes may reflect a consensus on how the company should proceed, and then FDA may reverse its position once the application is submitted. To say that this happens is not to defend it.
The pre-IDE process does not provide absolute certainty. FDA may change its requirements for good reasons such as new scientific information or significant changes in clinical practice or, unfortunately, for less compelling reasons. Companies therefore need to be alert for developments that may bear upon FDA’s willingness to accept the proposed clinical and regulatory plan.
Companies can, however, be fairly confident that objections expressed at the pre-IDE meeting will not dissipate with the passage of time. If there are strong objections to the intended use, or the staffers say that a PMA will be needed, companies should pay close heed. Companies need to listen very carefully; the objections may take the form of pointed questions. To put this in diagnostic terms, the negative predictive value of pre-IDE meetings is very high, while the positive predictive value is not as robust.
These caveats notwithstanding, the sponsor should make sure that there is some agreement on the key points before the meeting adjourns. There may be issues that the sponsor and FDA acknowledge are left unresolved. It is important, though, for the sponsor to try to achieve an understanding with FDA on the pivotal issues. The sponsor may therefore want to assign some team member the responsibility of summing up the meeting outcome before the meeting ends. Subsequently, the sponsor should submit minutes to memorialize the meeting.
Used properly, pre-IDE meetings can be valuable tools, benefiting both FDA and the sponsor. It, therefore, behooves IVD companies to make the most of each pre-IDE meeting they have.