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*Osseointegration Quality Registry Project

Active

Federal

Contract Overview

Solicitation details, issuing organization, response deadlines, documents, and interested companies for this government contract opportunity.

AI Contract Overview

The Osseointegration Quality Registry Project, managed by the Food and Drug Administration, aims to expand a comprehensive database of real-world clinical experience regarding osseoanchored devices implanted in various anatomical locations. By collecting detailed data on device performance, patient outcomes, and adverse events across multiple clinical sites in the United States, the initiative seeks to provide critical evidence to benefit patients, healthcare providers, device manufacturers, and regulatory bodies. The primary goal is to enhance the safety and effectiveness of high-risk devices while fostering broader innovation throughout the product lifecycle. To achieve these objectives, the project focuses on refining essential data elements, including patient-reported measures and clinical outcomes, and establishing a robust stakeholder data governance framework. This involves forming a steering committee to oversee decision-making authority and adjudicate disputes regarding data access. Additionally, the project will develop documented standards for data quality, privacy compliance, and lifecycle management to ensure the registry remains a secure and reliable source of multidisciplinary evidence.

General Info

FDA project collecting real-world data on osseoanchored devices to improve safety and effectiveness.

Agency

Food and Drug Administration → Food And Drug Administration

NAICS

541715 - Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)

Place of Performance

USA

Set-Aside

NONE

Documents

No documents available

Documents will appear here when they are available.

AI Contract Breakdown

Uniform Contract Format

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Timeline

PostedJan 1

forecast

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Organization & Contact Information

AgencyFood and Drug Administration → Food And Drug Administration

Contacts2 people available

OfficeN/A

Organization / AgencyFood and Drug Administration → Food And Drug Administration

Office AddressN/A

Contacts

Cdrh Acquisition Liaison

contact@example.gov

To Be Determined To Be DeterminedContracting Officer

Full Description

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.