This Government Contract opportunity was posted on October 26, 2009. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Heart Disease Regisrty for Pediatric Patients
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The Food and Drug Administration is seeking proposals for the development of a Congenital Heart Disease Registry for Pediatric Patients to improve post-market surveillance and provide reference data for premarket clinical trial designs. The registry aims to address current gaps in standard definitions and database linking to better assess the prevalence, demographics, management, and outcomes of pediatric patients undergoing diagnostic catheterization and catheter-based interventions across the United States. By capturing long-term clinical outcomes and imaging, the initiative intends to expedite new device approvals, enhance performance benchmarking, and reduce unnecessary patient radiation exposure. This procurement, identified by solicitation number 09-223-SOL-00214, will be awarded as a Firm Fixed Price contract with a total performance period of five years, consisting of one base year and four option years. The solicitation is open for full and open competition under FAR Part 15, and interested offerors must be registered in the Central Contract Registration database to be eligible for an award. The project will be managed out of Rockville, Maryland, and is designed to significantly increase the availability of data regarding device use following FDA approval.
General Info
Agency
Contract Value
$100,000Place of Performance
5630 Fisher Lane, ROCKVILLE, MD, 20857, USASet-Aside
Award Issued Date
Documents
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Timeline
Submission Closed
Organization & Contact Information
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