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What an awesome question. You only have 60 minutes to ask the FDA questions during a pre-submission meeting. Conventional wisdom is to spend 15 minutes with introductions, 30 minutes asking questions and finish with 15 minutes summarizing action items. Don’t do that.
If I were trying to establish a relationship with a new supplier, I might spend 15 minutes on introductions–or more. The purpose of a pre-sub meeting is to ask the FDA questions that will help you prepare your submission. You should focus as much time as possible on asking your most important questions.
Names and titles of all attendees can be communicated in advance of the meeting. Five minutes is more than enough for introductions. After introductions, you should only ask the most important questions, and you shouldn’t waste time arguing with the FDA.
The most important question is if your predicate is acceptable. If you select the wrong predicate, your entire submission may be jeopardized, or you may have to repeat comparative testing with a new predicate. The balance of your questions should focus on testing requirements. But not all tests are critical. The critical tests are the tests that take the longest, and the tests that cost the most money. If the test is quick and inexpensive, save those questions for last. You can also ask clarification questions in a supplement to the pre-submission.
You definitely should summarize action items, but this does not require 15 minutes. Typical actions items are: 1) submitting draft meeting minutes, and 2) providing additional data to the FDA in a supplement. The FDA might even be responsible for getting you additional information. Five minutes is probably all you need.
If you want to learn more about 510(k) pre-submission meetings, register for Thursday’s free webinar:
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Anil Bhalani My experience is different.
The FDA expects you to have your questions in the submission and they will answer those questions based on the information provided to support an answer. You have 60 minutes for the entire discussion including personal introductions (be real brief, 2 minutes), device background (5 minutes), why you are they, what you need etc. etc. So stay to the script, because the FDA will. Provide all you can in advance....everything you dot need to discuss at the meeting (background information, data, etc.). Go direct to what you want. The FDA reads and comes prepared with what you provided. If your question is not in the submission or not supported, don't expect an answer, or expect a request for more information in a supplemental submission. Best that the questions are in writing so they get answered. And write your minutes correctly, as they are very helpful. The pre-submission does get cited in the 510k or PMA submission.
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Hi Rob, I'm glad to see you addressed the question I submitted for the webinar. Looking forward to hearing the webinar!
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