Procurement Summary
Country: USA
Summary: Rapid Sterility Instrument
Deadline: 10 Mar 2026
Posting Date: 05 Mar 2026
Other Information
Notice Type: Tender
TOT Ref.No.: 137177751
Document Ref. No.: FDA-SSN-132933
Financier: Self Financed
Purchaser Ownership: Public
Tender Value: Refer Document
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MARKET RESEARCH PURPOSES ONLY
NOT A REQUEST FOR PROPOSAL OR SOLICITATION
The U.S. Food and Drug Administration (FDA), Office of Acquisitions and Grants Services (OAGS) is issuing this source sought announcement on behalf of the Irvine Medical Products Laboratory (IRVLMP), in order to determine if there are existing small business sources capable of providing a Rapid Sterility Instrument. Other than small business concerns, especially vendors who may be able to offer domestic products, are also encouraged to submit a capability statement that provides company information, as well as information demonstrating that it can meet all of the minimum requirements included below, to include the country of manufacture of products offered.
If your firm is considered a small business source under North American Industry Classification System (NAICS) Code 334516 - Analytical Laboratory Instrument Manufacturing; with a Small Business Size Standard of 1, 000 employees and you believe that your firm would be able to provide the FDA with the supplies/services described below, please submit an email to Warren.Dutter@fda.hhs.gov.
Background:
The Food and Drug Administration (FDA), Irvine Medical Products Laboratory (IRVLMP), is an ISO/IEC 17025 accredited regulatory testing laboratory that performs microbiological analyses of medical products to determine compliance with United States Pharmacopeia (USP) requirements and other applicable regulatory standards. Sterility testing conducted by the laboratory plays a critical role in supporting regulatory enforcement actions, compliance determinations, and public health protection.
Traditional sterility testing under USP requires extended incubation periods, which may delay final results. In high-priority or time-sensitive situations, delays in sterility determinations can impact the FDA-s ability to take timely regulatory or public health action.
To enhance responsiveness in critical cases, IRVLMP requires a Rapid Ster...
Notice ID: fda-ssn-132933
Department/Ind. Agency: health and human services, department of
Sub-tier: food and drug administration
Office: fda office of acq grant svcs
Product Service Code: 6640 - laboratory equipment and supplies
NAICS Code: 334516 - Analytical Laboratory Instrument Manufacturing
Inactive Dates: mar 25, 2026
Inactive Policy: 15 days after response date
Documents
Tender Notice