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Biocompatibility and the Pre-sub meeting – the Devil is in the Details

Biocompatibility and the Pre-sub meeting – the Devil is in the Details

BiocompCHATibility vor 6 Jahren

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37:56

Podcast

BiocompCHATibility

38 Episoden

A podcast dedicated to medical device biocompatibility

Wissenschaft Gesundheit & Fitness

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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 Porter

Discussion points include:

How is a presub meeting useful in evaluating the biological
safety of medical devices

What types of questions are useful to include in a
presub

What can you expect the FDA to provide to you in a presub

How can you insure the data you are getting from
extractables/leachables program will be most useful

What can you do to insure the proper FDA personnel is present
to answer the questions you have in a Presub meeting

Opinions are their own and do not reflect that of their current
or former employers.