FDA Steps Up Focus On Computational Modeling For Devices With Draft Guidance
This article was originally published in The Gray Sheet
The draft guidance outlines information on computational and simulation modeling studies that should be included in FDA device submissions. FDA has been encouraging companies to focus on modeling studies with a goal that they could eventually replace costly bench and animal studies.
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The document, which finalizes a 2014 draft guidance, details 15 key areas device-makers should include in device-submission reports on computer modeling and simulation.
The public-private partnership created to advance medical device regulatory science is starting 2014 with a renewed focus on its three projects and plans to possibly add a fourth to the mix.
FDA is moving ahead with development of a digital library for computer modeling and simulation tools for device development as well as an international standard for the verification and validation of such models. It recently hosted a stakeholder workshop to gain more feedback on the project.