Companion diagnostics and the FDA pre-submission programme

Article from TOPRA,  Regulatory Rapporteur – Vol 10, No 2, February 2013

Overview: In 1995, as part of the FDA Modernization Act, the US FDA introduced the pre-investigational device exemption (pre-IDE) meeting process. Initially, the intent of the pre-IDE meeting was similar to the preinvestigational new drug (pre-IND) meeting used by the FDA – to provide an opportunity for sponsors to talk to the agency about clinical trial designs prior to their execution. The goal was to streamline the review process by giving sponsors the opportunity to get feedback from the agency prior to submitting an IDE application.Over the years, the scope of the pre-IDE meeting has expanded. Today, sponsors use the pre-IDE process as a way of obtaining comments from the agency on a wide array of questions, from “intended use” statements to regulatory pathways to the use of retrospective clinical samples. As the pre-IDE process has grown beyond its original goals, there has been some confusion in the industry as to when to submit a pre-IDE document and meeting request. The ambiguity around the process and the contents of a pre-IDE submission has proved challenging to companies developing their first device. It has also been a source of confusion for drug companies seeking to develop a companion diagnostic, as they are used to a more structured IND process with clearly defined timelines and deliverables. As a result, on 13 July 2012 the FDA published “Draft Guidance for Industry and FDA Staff - Medical Devices: The Pre-Submission Program and Meetings with FDA Staff”. Although a draft guidance, the FDA has requested that all medical device and in vitro diagnostic (IVD) manufacturers begin to use this new process in place of the existing preIDE process. The new pre-submission programme adds more structure to the communications with the FDA and provides more detailed guidance to sponsors as to the information required for each submission type.While the new pre-submission programme should improve interactions between the FDA and sponsors, there are still some questions regarding how best to use the process, particularly when it comes to developing a companion diagnostic. In this article we will outline the new pre-submission programme, discuss the logistics of drafting and submitting pre-submission documents to the FDA, and offer some advice as to how to incorporate this new process into the co-development timelines for companion diagnostics.

Authors: David Kern, Senior Director, and Mya Thomae, CEO, Myraqa Inc, California, US.

Reference: Companion diagnostics and the FDA pre-submission programme