Hi Carolyn,
Regulatory Affairs Associates (RAA) was just at FDA last week for a pre-sub meeting on a device that did not fall into a standard pathway. While Marc is correct in that you can conduct a pre-sub meeting or file a 513(g), we feel it is better to meet with FDA in person. This is especially true for a first meeting as you want to meet the panel who will be reviewing your device submission and interact with them on a more personal level. Many times FDA does not fully understand a device or interprets something in the wrong way, and an in person meeting provides the opportunity to overcome that issue.
You will need to prepare a request and briefing package. In the briefing packaging you need to provide a good amount of detail about the device and its intended use. You should propose a regulatory strategy (510k, de novo, PMA), propose predicates, proposed testing and propose clinical studies if needed. You should have a list of questions (3-5 only).
For this most recent meeting, FDA provided a great deal of feed back on the regulatory pathway, the proposed testing and study designs, and invited the sponsor to submit any supplements necessary to gain FDA concurrence on the redesigned study or testing.
RAA is located in Bloomfield Hills, MI. If you would like to discuss this issue further or see how RAA can assist, please send me an email and we can schedule a time to talk. (
mtomasovich@regaffairs.net)
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Michael Tomasovich
Director Business Development
Regulatory Affairs Associates
Inkster MI
United States
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Original Message:
Sent: 07-22-2014 07:40
From: Marc Sanchez
Subject: Pre-submission meeting
Carolyn,
I've worked on a number of these and submitted a request similar to your scenario a couple of weeks ago. Reviewers are sensitive to the limited scope of pre-submission meetings. If you are unsure about the regulatory pathway they will be the first to tell you a pre-submission may not be the route and issue a RTA. The balance is between a pre-submission (free) and 513(g) (fee based) review. The reviews can be done in parallel if there is concern about a predicate. That is what I am currently engaged in - a pre-submission meeting asking about the predicate and a 513(g) asking about classification and regulatory pathway.
I'm happy to provide assistance if you need it.
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Marc Sanchez
Attorney and Regulatory Consultant
Atlanta GA
United States
msanchez@fdaatty.com
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Original Message:
Sent: 07-21-2014 10:52
From: Carolyn Wright
Subject: Pre-submission meeting
Hi I wanted to know if anyone had recently conducted a pre-submission meeting with the FDA with the desire to confirm a regulatory strategy for a new device that did not clearly fall into an established regulatory pathway?
Did you use a meeting as your method of feedback or a teleconference?
Who was in attendance at your meeting?
If you used a teleconference was it a phone call or a video chat? If chat what electonic system did you use?
Thanks for your feedback,
Carolyn
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Carolyn Wright
Amway
Ada MI
United States
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