Justification for Exception to Fair Opportunity (JEFO) – ANSYS Multi-Physics Simulation Software Suite

The FDA is seeking to continue the provision of the ANSYS Multi-Physics Simulation Software Suite, including licenses, maintenance, and technical support. This action is a logical follow-on to a previously competed order and is being executed via bilateral modification to exercise Option Year Two. The software provides advanced computational modeling and simulation capabilities used by the FDA to conduct regulatory science and in silico research and to support the review of medical products. • The estimated value of the proposed action is $238,171.73. • The requirement is for continued access to the ANSYS Multi-Physics Simulation Software Suite. • The software is utilized across multiple FDA centers, including the Center for Devices and Radiological Health (CDRH) and the Center for Drug Evaluation and Research (CDER). • The services are essential to maintaining ongoing research, analysis, and regulatory review activities.