2026 Mandatory Non-Device Software Report

Past New Requirement Updated

Agency
Solicitation expected
Estimated value
$250,000 to $700,000
Set-aside
No set-aside

Forecast facts

Anticipated award
NAICS code
923120 Administration of Public Health Programs
Points of contact

Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.

About this forecast

The Department of Health and Human Services Food and Drug Administration (FDA) is forecasting a new requirement for a 2026 Mandatory Non-Device Software Report, aligned with Section 3060(b) of the Cures Act. The contract focuses on producing a comprehensive report analyzing risks and benefits to health, with an estimated solicitation release date of July 1, 2026, and an anticipated award date of September 1, 2026. This opportunity falls under the Administration of Public Health Programs NAICS code 923120.

While specific award values and budget ranges are not currently available, the contract will require detailed analysis and reporting on health-related software risks and benefits. The primary point of contact for this opportunity is Joshua Holliday, who can be reached at joshua.holliday@fda.hhs.gov within the FDA organization. Additional contract specifics such as place of performance, exact service quantities, and precise timeline details are not explicitly provided in the current forecast.

Forecast text

A report on risks and benefits to health in conformance with Section 3060(b) of the Cures Act

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