FDA Seeks Input On Computer Modeling Library For Device Development
This article was originally published in The Gray Sheet
Executive Summary
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.
You may also be interested in...
FDA Issues How-To On Computational Modeling Reports
The document, which finalizes a 2014 draft guidance, details 15 key areas device-makers should include in device-submission reports on computer modeling and simulation.
FDA Steps Up Focus On Computational Modeling For Devices With Draft Guidance
The draft guidance outlines information on computational and simulation modeling studies that should be included in FDA device submissions.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.
FDA Steps Up Focus On Computational Modeling For Devices With Draft Guidance
The draft guidance outlines information on computational and simulation modeling studies that should be included in FDA device submissions.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.