FDA - SubCutaneous Injection Site Simulator

The U.S. Food and Drug Administration is seeking market information for a standalone Subcutaneous Injection Site Simulator instrument system under solicitation number 75F40126SSN133239, a Sources Sought Notice issued to assess industry capability prior to potential future procurement. This action is not a solicitation for proposals and no contract will be awarded from this notice; it is a market survey designed to gather technical, commercial, and socioeconomic data from potential suppliers. Responses must be submitted via email only to Timothy Walbert at timothy.walbert@fda.hhs.gov by 2:00 p.m. Central Time on June 1, 2026, with the solicitation number clearly referenced in the subject line. Respondents are required to provide detailed business identification including their Unique Entity ID from SAM, business address, website, point of contact details, and socioeconomic status such as Small Business, Veteran-Owned Small Business, Service-Disabled Veteran-Owned Small Business, HUBZone Small Business, Small Disadvantaged Business, Women-Owned Small Business, or LGBTQ+-Owned Business. The NAICS code 334516 applies, with a small business size standard of 1,000 employees. Companies must also submit past performance data from the last three years for similar products or services, including client names, contract values, dates, and manufacturer details if the respondent is not the original manufacturer. The system must meet specific technical requirements including full software control over hardware components such as injection parameters, temperature regulation, and fraction collection scheduling with real-time monitoring and automated sequence execution. It must integrate seamlessly with external spectrophotometer systems for real-time data acquisition and export data in standard formats. The instrument must reliably operate unattended for over 24 hours and include standardized calibration tools for optical detection systems across all chambers. Deliverables include initial consumables, a demonstration kit, reference cartridges or matrices, comprehensive technical documentation, user manuals, maintenance schedules, and Material Safety Data Sheets for all materials. Training requirements mandate a minimum of one full day of on-site instruction covering hardware operation, software use for method development and data management, automated injection and fraction collector programming, optical system calibration, and integration with existing spectrophotometers. Technical support must be available during standard business hours (9 a.m. to 5 p.m. ET) with an initial response time of no more than two business days. Contractors must provide compliance certificates, safety certifications, and regulatory documentation upon system acceptance, which triggers