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

[Jacob Barhak]

Yes John,

This paper is helpful. I listened to it during the long drive I had - it
covers many issues and in multiple locations redirects th reader to
V&V40 which we are discussing in our paper.

I think it's a good idea to include this in the revised version of our
paper as a reference since reviewers asked for recent references.

This is timely.

           Jacob



On Sun, Dec 26, 2021 at 8:44 AM John Rice <john.rice at noboxes.org> wrote:

> 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 New draft guidance document from the FDA: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
> <https://www.fda.gov/regulatory-information/search-fda-guidance-documents/assessing-credibility-computational-modeling-and-simulation-medical-device-submissions>
>
> 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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