[Vp-integration-subgroup] Fwd: Update: Draft Guidance: Assessing Credibility of Computational Modeling and Simulation

Jacob Barhak jacob.barhak at gmail.com
Thu Jan 27 19:37:29 PST 2022


Greetings reproducibility and integration groups,

John Rice has sent this message. about the FDA document:
https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions

And indeed this is relevant to our work - in fact this was my suggestion
for the next activity.

FDA has released a request for comments for a document drafted. We actually
referred to this document in our paper.

I was planning to start a discussion on this paper so we can
submit responses, either individually or as a group or sub-groups after we
finish with the paper.

Yet since the paper is almost done and time is running short, it is perhaps
a good idea to discuss this now.

Looking forward to your feedback.

               Jacob
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