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

[Ruchira Datta]

New draft guidance document from the FDA: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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