FDA Seeks Input On Computer Modeling Library For Device Development

Article preview from "The Gray Sheet" - July 1, 2013

 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.

FDA Seeks Input On Computer Modeling Library For Device Development

Article preview from "The Gray Sheet" - July 1, 2013

FDA is moving forward with efforts to promote physiological computer models as a core development and evaluation tool for medical devices by seeking input from manufacturers and other experts.

In early June, the agency hosted its fifth workshop on computer models for medical devices. One day of the two-day meeting was devoted to FDA’s Digital Library of Modeling and Simulation, a proposed public repository of open-use models and simulations. The proposed library would store biomedical data, computational models and other reference materials relevant to computational modeling and simulation for devices. A separate segment of the workshop focused on development of standards for the verification and validation of models, allowing them to be used industry-wide.

Participants said they hope that the proliferation and promulgation of computer models will help engineers optimize medical devices in the pre-clinical stage of development. Computer models may eventually replace some costly benchmark and animal testing currently required in device development. 

Companies are sending in modeling and simulation [to FDA] as part of their regulatory process,” Arthur Erdman, a workshop participant and the director of the Medical Devices Center at the University of Minnesota in Minneapolis, told “The Gray Sheet.”

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