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Biocompatibility and the Pre-Submission Meeting – The Devil is in the Details


In this episode, Deanna Porter and Kent Grove from Abbott join our hosts to review the U.S. FDA pre-submission meeting process as it pertains to the biocompatibility of medical devices. The group will not only examine the current procedure for a pre-submission meeting, but also discuss how this opportunity to obtain feedback from the U.S. FDA prior to an intended submission can save valuable time, especially for programs containing chemical characterization or other complex testing protocols.

“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 pre-subs and take advantage of this meeting with the [U.S.] 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 pre-sub is knowing what you know and what you don’t know so you put the right detail into the pre-sub.” – 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 Porter

Discussion points include:

  • How a pre-submission meeting is useful in evaluating the biological safety of medical devices
  • Effective questions to include in a pre-submission meeting
  • What the U.S. FDA may provide in a pre-submission meeting
  • How to ensure data from the extractables/leachables program will be efficient

*Please note that the opinions discussed throughout the podcast are their own and do not reflect that of their current or former employers.

Also be sure to check out our Biocompatibility Strategy Navigator.