2026 Mandatory Non-Device Software Report

The contract entails the preparation of a detailed report analyzing the risks and benefits related to health, in compliance with Section 3060(b) of the Cures Act. This report is specifically focused on non-device software, reflecting the regulatory requirements for such products as outlined by the Food and Drug Administration (FDA). The task falls under the NAICS code 541611, which references administrative management and general management consulting services, indicating that the work involves substantial research and analysis to inform regulatory decisions. The project is scheduled for the year 2026, with a forecast posting date of March 11, 2026. The contract is managed by the FDA, with points of contact including a program acquisition liaison and a contracting officer to be determined. While some logistical details such as the place of performance and office address remain unspecified, communication and coordination will be facilitated through established FDA channels. The report produced under this contract will provide critical insights to ensure that health risks and benefits are thoroughly evaluated in the context of non-device software, advancing the agency’s mission to protect public health.