{"id":3038289,"date":"2023-12-28T09:36:33","date_gmt":"2023-12-28T14:36:33","guid":{"rendered":"https:\/\/wordpress-1016567-4521551.cloudwaysapps.com\/plato-data\/fda-guidance-on-assessing-the-credibility-of-computational-modeling-and-simulation-factors-goals-and-adequacy-assessment-fda\/"},"modified":"2023-12-28T09:36:33","modified_gmt":"2023-12-28T14:36:33","slug":"fda-guidance-on-assessing-the-credibility-of-computational-modeling-and-simulation-factors-goals-and-adequacy-assessment-fda","status":"publish","type":"station","link":"https:\/\/platodata.io\/plato-data\/fda-guidance-on-assessing-the-credibility-of-computational-modeling-and-simulation-factors-goals-and-adequacy-assessment-fda\/","title":{"rendered":"FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Factors, Goals, and Adequacy Assessment | FDA"},"content":{"rendered":"
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The article describes in detail the approach to be applied for credibility factors and credibility goals to be considered by the parties responsible for medical devices.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Table of content<\/span><\/h2>\n<\/div><\/div>\n

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The <\/span>Food and Drug Administration<\/b><\/a> (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to assessing the credibility of computational modeling and simulation in medical device submissions. <\/span>
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<\/span>The document provides an overview of the applicable regulatory requirements, as well as additional clarifications and recommendations to be taken into consideration by medical device manufacturers and other parties involved to ensure compliance with them. <\/span>
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<\/span>At the same time, provisions of the guidance are non-binding in their legal nature, nor are they intended to introduce new rules or impose new obligations. <\/span>
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<\/span>Moreover, the authority explicitly states that an alternative approach could be applied, provided such an approach is in line with the existing legal framework and has been agreed with the authority in advance. <\/span><\/p>\n

The scope of the guidance covers, inter alia, the aspects related to credibility factors and credibility goals.<\/span><\/p>\n<\/div><\/div>\n

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<\/span>Credibility Factors and Credibility Goals<\/strong><\/span><\/h2>\n

According to the guidance, in Step 5 of the framework, the focus is on defining credibility factors for planned credibility evidence and setting specific goals for each factor, along with a strategy to achieve these goals. <\/span>
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<\/span>The <\/span>ASME V&V 40<\/b> standard<\/b> is a key reference for understanding credibility factors. It categorizes credibility factors into various aspects like \u201c<\/span>Software Quality Assurance<\/b>\u201d, \u201c<\/span>Numerical code verification<\/b>\u201d, \u201c<\/span>Calculation verification<\/b>\u201d, \u201c<\/span>Validation<\/b>\u201d, and \u201c<\/span>Applicability<\/b>\u201d.<\/span><\/p>\n

To effectively establish these factors and goals, a series of sub-steps are recommended:
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