<html><head><meta http-equiv="content-type" content="text/html; charset=utf-8"></head><body dir="auto"><div dir="ltr"></div><div dir="ltr"><a href="https://www.fda.gov/medical-devices/medical-device-regulatory-science-research-programs-conducted-osel/credibility-computational-models-program-research-computational-models-and-simulation-associated">https://www.fda.gov/medical-devices/medical-device-regulatory-science-research-programs-conducted-osel/credibility-computational-models-program-research-computational-models-and-simulation-associated</a></div><div dir="ltr"><br>On Jan 27, 2022, at 22:37, Jacob Barhak <jacob.barhak@gmail.com> wrote:<br><br></div><div dir="ltr"><div dir="ltr">Greetings reproducibility and integration groups,<div><br></div><div>John Rice has sent this message. about the FDA document:</div><div><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions">https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions</a><br></div><div><br></div><div>And indeed this is relevant to our work - in fact this was my suggestion for the next activity. </div><div><br></div><div>FDA has released a request for comments for a document drafted. We actually referred to this document in our paper. </div><div><br></div><div>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.</div><div><br></div><div>Yet since the paper is almost done and time is running short, it is perhaps a good idea to discuss this now.</div><div><br></div><div>Looking forward to your feedback.</div><div><br></div><div> Jacob</div><div><br></div><div><img src="https://links.govdelivery.com/track?enid=ZWFzPTEmYnVsbGV0aW5yZWNpcGllbnRpZD0xMjU3MjEzOTE2MzctbCZzdWJzY3JpYmVyaWQ9MTI1NjEwMzAxMiZtc2lkPSZhdWlkPSZtYWlsaW5naWQ9MjAyMjAxMjcuNTI0NDUyNjEmbWVzc2FnZWlkPU1EQi1QUkQtQlVMLTIwMjIwMTI3LjUyNDQ1MjYxJmRhdGFiYXNlaWQ9MTAwMSZ0eXBlPW9wZW4mc2VyaWFsPTE3MDUxNDUyJmVtYWlsaWQ9am9obi5yaWNlQG5vYm94ZXMub3JnJnVzZXJpZD1qb2huLnJpY2VAbm9ib3hlcy5vcmcmdGFyZ2V0aWQ9JmZsPSZtdmlkPSZleHRyYT0mJiY=" width="1" height="1" alt="" style="border-width: 0px; border-style: hidden;" data-unique-identifier=""><br></div></div>
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