This Government Contract opportunity from Department Of Veterans Affairs was posted on May 6, 2026. The submission period has ended. Browse the details below for market research, or find similar active opportunities.
Regulatory Compliance & FDA Submission Support
Contract Overview
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The contract requires the preparation and submission of FDA 510(k) documentation for a Clitoral Therapy Device, encompassing comprehensive regulatory elements such as risk analysis, biocompatibility testing, labeling, and adherence to quality system requirements. All deliverables must align with FDA guidelines to establish substantial equivalence and secure market clearance, ensuring the device meets safety and efficacy standards for clinical use. The submission must be fully compliant with applicable regulatory frameworks and include supporting data that demonstrates the device’s performance and patient safety profile. This engagement is structured as a subcontract under the Department of Veterans Affairs through the Strategic Acquisition Center Fredericksburg, with a North American Industry Classification System code of 541690 reflecting specialized scientific and technical consulting services. The response deadline is January 6, 2026, and the work must be performed to meet federal regulatory expectations without specified geographic restrictions. The effort is focused solely on regulatory pathway execution and does not involve manufacturing, clinical trials, or post-market activities beyond the scope of the 510(k) submission package.
General Info
Agency
NAICS
Place of Performance
VASet-Aside
Documents
This scope was carved out of 36C10G26Q0004.
The full solicitation package (12 documents), including the RFP, is on the prime solicitation, not on this scope.
6515--Clitoral Therapy Device (CTD) (VA-24-00037945)
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Timeline
Submission Closed
Organization & Contact Information
Full Description
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