Two types of pre-IDE meetings are possible: meetings in which FDA provides “informal guidance” and meetings where FDA provides “formal guidance” as provided for in Section 201 of the FDA Modernization Act of 1997.
a. “Informal Guidance” Meetings. Sponsors are encouraged to meet with the Office of Device Evaluation (ODE), Reviewing Division before the IDE application is submitted for review so that the reviewing division can provide any advice/guidance which can be used in the development of supporting preclinical data or the investigational plan for incorporation into the IDE application. These meetings may take the form of telephone conference calls, video conferences, or face-to-face discussions. Regardless of the form of the pre-IDE meeting, all meetings should be recorded by the ODE reviewing division and reported on a quarterly basis to ODE senior management. Minutes of the meeting should include the date of the meeting, the attendees, whether material was submitted prior to the meeting for discussion/review by ODE staff, a summary of the discussion, and any recommendations or guidance provided by FDA.
b. “Formal Guidance” Meetings. A sponsor or applicant may submit a written request for a meeting to reach an agreement with FDA regarding FDA’s review of an investigational plan (including a clinical protocol). As required by the statute, this meeting should take place no later than 30 days after receipt of the request. The written request should include a detailed description of the device, a detailed description of the proposed conditions of use of the device, a proposed plan (including a clinical protocol) for determining whether there is a reasonable assurance of effectiveness, and, if available, information regarding the expected performance of the device. If an agreement is reached between FDA and the sponsor or applicant regarding the parameters of an investigational plan (including a clinical protocol), the terms of the agreement should be put in writing and made part of the administrative record by FDA.
c. Agreement Meeting. A sponsor or applicant may submit a written request for a meeting to reach an agreement with FDA regarding FDA’s review of an investigational plan (including a clinical protocol). The request and summary information should be submitted as a pre-IDE submission and identified as an agreement meeting request. This meeting should take place no later than 30 days after receipt of the request. The written request should include a detailed description of the device, a detailed description of the proposed conditions of use of the device, a proposed plan (including a clinical protocol) for determining whether there is a reasonable assurance of effectiveness, and, if available, information regarding the expected performance of the device. If an agreement is reached between the FDA and the sponsor or applicant regarding the parameters of an investigational plan (including a clinical protocol), the terms of the agreement are put in writing and made part of the administrative record by FDA.