FDA has recently released groundbreaking guidance known as the “Credibility Modelling Guidance.” This comprehensive framework marks a significant development in evaluating computational modeling within U.S. medical device premarket submissions.
Credibility Modelling Guidance
The guidance introduces a risk-informed approach that aims to enhance transparency and consistency in regulatory reviews of computational models used in medical devices. It covers various aspects such as scope, definitions, and a generalized framework, placing emphasis on critical factors like model risk, decision consequence, and credibility evidence categories.
For those delving into the specifics, the guidance outlines specific steps that manufacturers can follow. These include defining the question of interest, identifying evidence categories (e.g., code verification, in vivo validation), and proposing a systematic approach to assess the adequacy of credibility evidence.
This is a crucial resource for manufacturers looking to navigate the regulatory landscape effectively. It’s essentially a go-to manual for seeking FDA feedback on how to assess the credibility of computational models used in medical devices.
Overall, this guidance paved the way for the future of MedTech, offering insights and guidelines to elevate the standards of computational modeling within medical device development and regulatory compliance.
This guidance aims to enhance consistency and transparency in FDA reviews of submissions involving CM&S methods, thereby facilitating a smoother regulatory approval process for medical devices reliant on computational models. It would be advisable for manufacturers to familiarize themselves with this guidance and consider its recommendations when preparing their regulatory submissions.
