[Vp-integration-subgroup] More Re: Update: Draft Guidance: Assessing Credibility of Computational Modeling and Simulation

[John Rice]

https://www.fda.gov/medical-devices/medical-device-regulatory-science-research-programs-conducted-osel/credibility-computational-models-program-research-computational-models-and-simulation-associated

On Jan 27, 2022, at 22:37, Jacob Barhak <jacob.barhak at gmail.com> wrote:


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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