[Vp-reproduce-subgroup] Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions

[John Rice]

Ruchira, You are quick and so helpful. I knew this was coming and wanted before years end.  They did it!

(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. )   

All, 
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.  
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.  


On Dec 25, 2021, at 10:17, Ruchira Datta <ruchira.datta at gmail.com> wrote:


New draft guidance document from the FDA:

Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions | FDA

Figure 1, p. 12 is a flowchart

Table 1, p. 17 lists ten categories of credibility evidence

Figure 2 "Hypothetical example of setting credibility factor goals" is on p. 27 although it is referred to a little before that:

pp. 25–26 expands on Steps 5.1–5.3 of the flowchart. Step 5 is:

State credibility factors, state gradations and select credibility goals 
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