CDRH Clinical Study Service Contract
Closed Solicitation Posted
- Solicitation number
- 75F40126Q00193
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- No set-aside
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- Place of performance
- Silver Spring, Maryland, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration's Center for Devices and Radiological Health seeks clinical study services to validate an electrocardiography signal transformation framework for artificial intelligence and machine learning-enabled medical devices, with quotes due August 4, 2026, at 2:00 PM Eastern Time.
Place of performance is Silver Spring, Maryland, with all work performed remotely at the contractor's facilities. The procurement is Firm Fixed Price under FAR Part 12, NAICS 541715, PSC R425. The base period runs September 30, 2026 through September 29, 2027, with four optional one-year extensions through September 29, 2031.
The contractor must execute a prospective clinical study recruiting 150 subjects in the base year and 35 subjects in each option year, collecting concurrent 12-lead ECG recordings using FDA-approved devices with ground truth validation from imaging, echocardiography, or catheterization. Demographics must be balanced at 50% ± 4% male/female with specified age distributions and racial composition representative of the U.S. population. The contractor must also prepare a retrospective dataset of at least 4,000 subjects with synthetic wearable ECG signals based on FDA-developed algorithms.
Mandatory qualifications include established collaboration with federal institutions such as NIH or NSF; successful completion of at least five clinical studies; hospital affiliation within ten miles; and over ten years of independent experience each in artificial intelligence/machine learning algorithm development and wearable dataset analysis. Contractors must independently procure and bear all costs for reference and test ECG devices. No subcontracting is permitted for core contractor requirements.
Key deliverables include clinical study protocol (30 days after award), IRB approval (three months), and fully de-identified prospective and retrospective datasets with comprehensive clinical study reports (one year). Inspection and acceptance occur at the contractor's facilities via the Contracting Officer's Representative. Quotes must be submitted to Natalie.Brown@fda.hhs.gov as fully burdened firm-fixed-price proposals covering all direct labor, fringe, overhead, G&A, and profit.
Notice text
See attached RFQ
Files
| File | Type | Posted |
|---|---|---|
| Attachment A-Price Sheet RFQ_75F40126Q00193.xlsx | XLSX spreadsheet | |
| RFQ_75F40126Q00193.pdf | ||
| Sol_QR.docx | DOCX document | |
| Attachment A-Price Sheet RFQ_75F40126Q00193.xlsx | XLSX spreadsheet | |
| RFQ_75F40126Q00193.pdf |
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