FDA - SubCutaneous Injection Site Simulator

The FDA Office of Acquisition and Grant Services is conducting market research on the availability of a Subcutaneous Injection Site Simulator (SCISSOR) system, with responses due by June 1, 2026 at 2:00 pm Central Time. This Sources Sought Notice does not obligate the government to award a contract and no reimbursement will be made for response costs.

The SCISSOR system must be a complete in vitro subcutaneous injection site simulator with at least six independent chambers featuring integrated optical detection systems and automated sampling capabilities. Required specifications include independent temperature and flow control (32–37°C range), an automated injection system with programmable parameters, optical detection with fiber optic probes and UV-visible spectroscopy capability, an automated fraction collection system with a minimum of 30 vials per chamber, calibration and standardization tools, and comprehensive software control with real-time monitoring. The system must support integration with existing FDA spectrophotometer systems (Rainbow R2 or equivalent).

The vendor must provide a minimum one-year full manufacturer warranty, complete installation with performance verification testing, comprehensive on-site training (minimum one full day), and ongoing technical support via phone and email during regular business hours with maximum 2 business day response times. The vendor must demonstrate capability to deliver within 5 business days of service initiation.

Responses must include company information with SAM Unique Entity ID and business size status, past performance data from the last three years, descriptive literature and technical specifications, applicable GSA Schedule contracts and government-wide contract information, and place of manufacture details. Though not required, informational pricing would be helpful for market research. Responses should be submitted by email to timothy.walbert@fda.hhs.gov with notice number 75F40126SSN133239 in the subject line. NAICS 334516 (Analytical Laboratory Instrument Manufacturing); PSC 6640.