*Open-Source Tool for UDI Capture at the Point of Patient Care
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $700,000 to $1,500,000
- Set-aside
- No set-aside
Forecast facts
- Anticipated award
- NAICS code
- Not on record
- Points of contact
-
- CDRH Acquisition Liaison cdhracquisitions@fda.hhs.gov
Forecast details come from HHS's procurement forecast. Agencies' dates and values are estimates.
About this forecast
The FDA is procuring development of an open-source tool for capture of Unique Device Identifiers (UDI) at the point of patient care, with solicitation estimated for release July 1, 2026 and award anticipated January 1, 2027. The requirement addresses a documented gap in UDI traceability for non-sterile medical devices, particularly orthopedic implants, which lose their UDI labels during hospital sterilization processes and cannot be directly marked due to size, geometry, or substrate constraints. The solution will build on prior FDA Innovation Lab and OSEL image recognition work and deliver a validated, open-source tool for dissemination to hospitals and healthcare providers to support patient safety, post-market surveillance, and adverse event tracking.
The estimated award value ranges from $700,000 to $1.5 million. Inquiries should be directed to cdhracquisitions@fda.hhs.gov.
Forecast text
Point-of-care capture of Unique Device Identifiers (UDI) for non-sterile medical devices presents a persistent and well-documented challenge in the clinical setting. Non-sterile implants - such as orthopedic screws, plates, and rods - are delivered from the manufacturer in labeled packaging but must be sterilized by the hospital prior to use. The sterilization process requires removal of the device from its packaging, which is typically the only carrier of the UDI label. Additionally, the size, geometry, and substrate composition of many implants make direct device marking technically impractical or infeasible under current standards. This gap results in significant loss of traceability at the moment of implantation, undermining the foundational goals of the UDI system: patient safety, post-market surveillance, and adverse event tracking.In 2018, the FDA Innovation Lab and CDRH's Office of Science and Engineering Laboratories (OSEL) initiated a Critical Path-funded project exploring image recognition as an approach to identify UDIs from device packaging prior to sterilization. This proposal is to build on that prior to work towards a validated, open-source solution that can be disseminated for use by hospitals and healthcare providers, complementing existing commercial offerings.
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