Pre IDE Process

Sponsors are encouraged to contact FDA to obtain further guidance prior to the submission of an IDE application. This will be especially beneficial to new sponsors who have not previously had contact with the agency and for sponsors proposing to study new technologies or new uses for existing technologies. Early interaction with the agency should help to increase the sponsor's understanding of FDA requirements, regulations, and guidance documents, and will allow FDA personnel to familiarize themselves with the new technologies.

Informal Guidance Meeting

Sponsors are encouraged to meet with the 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 pre-clinical 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. The sponsor should contact the reviewing division directly or may contact the IDE staff for assistance.

Formal Guidance Meetings

Determination Meeting

• A sponsor or applicant anticipating the submission of a PMA may submit a written request to discuss the type of valid scientific evidence that will be necessary to demonstrate that the device is effective for its intended use.
• The request and summary information for a meeting should be submitted as a pre-IDE submission and identified as a determination meeting request.
• FDA's determination is provided to the applicant in writing within 30 days following the meeting.

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 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.