Opportunity

SAM #75F40126SSN133239

FDA Solicitation for Subcutaneous Injection Site Simulator (SCISSOR) System and Support

Buyer

FDA Office of the Associate General Counsel for Administrative Law

Posted

May 27, 2026

Respond By

June 01, 2026

Identifier

75F40126SSN133239

NAICS

334516, 541715, 339112

The U.S. Food and Drug Administration (FDA) is seeking a stand-alone Subcutaneous Injection Site Simulator (SCISSOR) system for its Center for Drug Evaluation and Review (CDER), Division of Pharmaceutical Quality Research V (DPQRV). - Government Buyer: - U.S. Food and Drug Administration (FDA), Center for Drug Evaluation and Review (CDER), Division of Pharmaceutical Quality Research V (DPQRV) - Procurement managed by FDA Office of Acquisition and Grant Services, Rockville, MD - Products/Services Requested: - Subcutaneous Injection Site Simulator (SCISSOR) system - Must include multiple independent chambers (minimum six) - Integrated optical detection and monitoring - Automated sampling and fraction collection - Temperature and flow control - Automated injection system - Calibration and standardization tools - Consumables and accessories - Software control and data management - Installation, training, warranty, and service support - Installation of SCISSOR system (including integration with FDA spectrophotometer) - On-site training for FDA personnel (hardware, software, maintenance, troubleshooting) - Service and support (technical support, software updates, replacement parts, remote diagnostics) - OEMs and Vendors: - No specific OEMs or vendors are named in the solicitation - Unique/Notable Requirements: - System must be capable of integration with FDA spectrophotometer - Automated and software-controlled operation is required - Comprehensive installation, training, and ongoing support must be provided - Targeted to small businesses under NAICS 334516, but open to all capable vendors - Delivery/Performance Locations: - Delivery to U.S. FDA CDER DPQRV, Bldg. 64, 1st Floor Loading Dock, 10903 New Hampshire Avenue, Silver Spring, MD 20993-0002 - Contracting office at 11601 Landsdown St, Floor 13, Rockville, MD 20852

Description

This FDA requirement is for a stand-alone Subcutaneous Injection Site Simulator instrument system.  Please see attached PDF file titled:  FDA_75F40126SSN133239.

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