FDA Subcutaneous Injection Site Simulator (SCISSOR)

The FDA's Division of Pharmaceutical Quality Research V seeks a complete in vitro Subcutaneous Injection Site Simulator (SCISSOR) system, with quotes due August 5, 2026 at 2:00 pm CDT (extended from July 31 via Amendment 01). The procurement is a total small business set-aside; only small businesses actively registered in SAM.gov are eligible.

Place of performance is the FDA's Silver Spring, Maryland facility (Building 64, 1st Floor Loading Dock, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002), with FOB Destination delivery. NAICS code 334516 (Analytical Laboratory Equipment Manufacturing) applies, with a small business size standard of 1,000 employees.

The SCISSOR system must include at least six independent chambers with independent temperature (32–37°C) and flow control; integrated camera or imaging system for real-time visual monitoring; manual or automated injection capability; simultaneous visual and spectroscopic monitoring; automated injection system with reproducible volumes and programmable parameters; optical detection system with UV-visible spectroscopy capability and fiber optic probes; automated fraction collection system with minimum 30 vials per chamber (180 total); calibration and standardization tools; and software with complete hardware control, multi-chamber monitoring, real-time status display, automated sequencing, data export in standard formats, and audit trail capabilities. The contractor must provide complete installation, minimum one full day on-site training, technical support via phone and email during regular business hours with maximum two-business-day response time, initial consumables, demonstration kits, and comprehensive documentation.

The contract is Firm Fixed-Price with one-year full manufacturer's warranty from FDA acceptance. Prices must remain firm through September 30, 2026. Payment terms are Net 30 after government acceptance. Submissions must include technical compliance demonstration, detailed pricing, SAM registration confirmation, and an Accessibility Conformance Report addressing Section 508 compliance.