<html><head><meta http-equiv="content-type" content="text/html; charset=utf-8"></head><body dir="auto"><div dir="ltr"></div><div dir="ltr"><div dir="ltr">Ruchira, You are quick and so helpful. I knew this was coming and wanted before years end. They did it!</div><div dir="ltr"><br></div><div dir="ltr">(Someone?, I’ve not read it all yet but this may need REPRODUCIBILITY added to definitions and maybe incorporated into the body to discuss modelers need to address it as a source of model model accreditation data. ) </div><div dir="ltr"><br></div><div dir="ltr">All, </div><div dir="ltr">This is stuff I’ve been trying to tell academics that they need to master and use routinely for any model that they might ever hope to be USEFUL to anyone other than themselves for fulfilling a grant deliverable requirement. If the finding agencies don’t start some kind of accreditation evidence std for model product we will waste a lot of time and intellectual talent. </div><div dir="ltr">Will admit there MAY be some important “benefits” (new tools, techniques and even science discovery) in just modeling but funding sources must start distinguishing between funding modeling, and funding for useful models I.e. to provide new useable/applied knowledge or reusable/adaptable models as products. </div><br class="Apple-interchange-newline" style="-webkit-text-size-adjust: auto;"></div><div dir="ltr"><br>On Dec 25, 2021, at 10:17, Ruchira Datta <ruchira.datta@gmail.com> wrote:<br><br></div><div dir="ltr"><div dir="ltr"><div dir="ltr">New draft guidance document from the FDA:<br><br><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions">Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions | FDA</a><br></div><div dir="ltr"><br></div><div>Figure 1, p. 12 is a flowchart</div><div><br></div><div>Table 1, p. 17 lists ten categories of credibility evidence</div><div><br></div><div>Figure 2 "Hypothetical example of setting credibility factor goals" is on p. 27 although it is referred to a little before that:</div><div><br></div><div>pp. 25–26 expands on Steps 5.1–5.3 of the flowchart. Step 5 is:<br><br>State credibility factors, state gradations and select credibility goals </div></div>
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