In this episode our hosts are joined by 2 esteemed colleagues from Abbott: Deanna Porter, Kent Grove to discuss the US FDA pre-sub meeting process as it pertains to the biocompatibility of Medical devices.The group will review the current procedure for a pre-sub meeting and how this opportunity to obtain FDA feedback prior to an intended submission can be very useful, especially for programs containing chemical characterization or other complex testing protocols.It’s a great opportunity to receive feedback and responses to specific questions, although not guaranteeing approval, the guests show today how using this process saves them valuable time in their biological evaluation.“When you see 3 responses in a week with 15-17 questions about biocomp, it makes you wonder if there’s a way to make this process more effective.” – Don Pohl“We focus the presubs and take advantage of this meeting with the FDA” – Kent Grove“We like to focus the meeting on a specific need, so that we can really zero in on the responses and the guidance that we specifically need.” -Deanna Porter“Little things can make a difference in profile.” -Kent Grove“The key to a successful presub is knowing what you know and what you don’t know so you put the right detail into the presub.” -Don Pohl “Have very pointed questions, not presenting a lot of ambiguity, making sure you understand what you want to get out of them, what answer you are seeking, so that it speaks specifically to the input that you are requiring them to provide.” -Deanna PorterDiscussion points include:How is a presub meeting useful in evaluating the biological safety of medical devicesWhat types of questions are useful to include in a presub What can you expect the FDA to provide to you in a presubHow can you insure the data you are getting from extractables/leachables program will be most usefulWhat can you do to insure the proper FDA personnel is present to answer the questions you have in a Presub meetingOpinions are their own and do not reflect that of their current or former employers.

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