*Osseointegration Quality Registry Project
Past New Requirement Updated
- Agency
-
Food and Drug Administration
Department of Health and Human Services
- Solicitation expected
- Estimated value
- $1,500,000 to $3,000,000
- 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 Food and Drug Administration is procuring services to establish and manage the Osseointegration Quality Registry Project, a comprehensive database collecting real-world clinical data on osseoanchored devices implanted across multiple anatomical locations at clinical sites throughout the United States. The project requires identifying and refining key data elements for device evaluation—including clinical outcomes, patient-reported measures, device performance metrics, and adverse event tracking—and establishing stakeholder data governance through a steering committee responsible for data access policies, quality standards, privacy compliance, and lifecycle management. The estimated solicitation release date is July 1, 2026, with an estimated award date of January 1, 2027.
The estimated award value ranges from $1.5 million to $3 million. The registry will leverage multidisciplinary real-world evidence to systematically evaluate osseoanchored devices across their entire product lifecycle, benefiting patients, healthcare providers, device manufacturers, and the FDA. Inquiries should be directed to the FDA's Center for Devices and Radiological Health Acquisitions mailbox at cdhracquisitions@fda.hhs.gov.
Forecast text
Walter Reed's Osseointegration Quality Registry represents a substantial and growing database of real-world clinical experience that collects detailed data on device use and both short- and long -term patient outcomes for osseoanchored devices implanted in various anatomical locations (e.g., transfemoral or transhumeral indications) from a broad range of clinical sites across the United States. The team will collaborate with the Walter Reed and other stakeholders to establish a comprehensive registry specifically designed to leverage multidisciplinary real-world evidence for the systematic evaluation of osseoanchored devices across their entire product lifecycle. The project will focus on the following desired process and outcomes:(1)Identify and refine key data elements essential for comprehensive device evaluation (including clinical outcomes, patient-reported measures, device performance metrics, and adverse event tracking protocols). The data collection through the registry expansion will benefit stakeholders including patients, healthcare providers, device manufacturers and FDA, and will help promote both the safety and effectiveness of high-risk devices and broader device innovation. (2)Establish Stakeholder Data Governance. Engage stakeholders collaboratively to define the registry's purpose, scope, and decision-making authority. Convene a steering committee responsible for adjudicating disputes related to data access and policy changes. Develop and document comprehensive governance standards covering data quality, privacy compliance, data access protocols, and data lifecycle management.
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