Robert,
My only comment is that is a lot to "throw" at FDA in one session. Most Q-Sub meetings are limited to 1 hour, sometimes you can get 1.5 hours, on rare occasions 2 hours. Your organisation should think about the time limitations, the amount of information presented in the Q-Sub (pre-sub) packet, and what feedback you are wanting to get from the FDA. This of course also deals with the complexity of the device itself, risk levels, and that you are looking at a De Novo sounds like it is already a novel device. While you can have all of this in one Q-Sub meeting, I have worked with companies that we did classification in one Q-Sub, de novo position in second Q-Sub, and clinical trial protocol review in third Q-Sub. While that took longer time period, we could build upon each one and also educate the FDA reviewer(s) and team along the way. Send them too much information and it just overwhelms them. Think about when you get an email from a colleague .. would you rather answer 3 short emails or when you get that "walk of text" it just seems to daunting to even start reading.
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Richard Vincins RAC
Vice President Regulatory Affairs
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Original Message:
Sent: 01-May-2018 16:33
From: Robert Wilkinson
Subject: Expedited Access Pathway and Direct de novo Request Pre Subs
A manufacturer has a device which will qualify for the Expedited Access Pathway (EAP) for devices intended for an unmet medical need for a life threatening condition. The manufacturer also believes that the device will qualify for a "direct de novo" request.
The first step of a manufacturer's proposed regulatory strategy would be to organize the EAP information in a Pre-Sub Meeting request explaining why the device meets the EAP criteria. The manufacturer is also planning to detail the plans to submit the device utilizing the "direct de novo" method under the same Pre-Sub Meeting request.
Would it be acceptable to include the information required for request for designation as an EAP Device ("EAP Designation"), the EAP Data Development Plan, and the "direct de novo" request for an EAP Device in the same Pre-Sub Briefing Package? What is an acceptable alternative method of covering all three topics short of having three separate meetings ?
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Robert Wilkinson
President
Port Barrington IL
United States
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