2026 Mandatory Non-Device Software Report

The Food and Drug Administration is forecasting a mandatory reporting requirement for 2026 related to non-device software used in healthcare, in alignment with Section 3060(b) of the 21st Century Cures Act. This report will assess the health risks and benefits associated with such software, focusing on its impact on patient safety, clinical outcomes, and public health. The contract is categorized under NAICS code 541611, indicating it pertains to scientific research and development services, and is intended to elicit expert analysis and documentation that meets federal regulatory standards. The report will serve as a foundational tool for FDA oversight of software functioning as a medical product, ensuring transparency and evidence-based evaluation of digital health technologies. The procurement is being managed by the FDA’s Center for Devices and Radiological Health, with the primary point of contact for program inquiries being the CDRH Acquisition Liaison at cdrhacquisitions@fda.hhs.gov. The contracting officer position has not yet been filled, suggesting the solicitation process is still in the preliminary forecasting phase and formal bid documentation has not been issued. Although the place of performance and specific set-aside provisions are unspecified, the work is expected to be performed remotely or via electronic submission, given the nature of software analysis. The forecast indicates the agency's intent to formally release a solicitation in the near future, with an emphasis on qualified contractors capable of conducting rigorous, compliant evaluations of health software under federal guidelines.