FDA - SubCutaneous Injection Site Simulator
Overview
Buyer
Place of Performance
NAICS
PSC
Set Aside
Original Source
Timeline
Qualification Details
Fit reasons
- NAICS alignment with historical contract wins in similar service areas.
- Scope strongly matches core technical capabilities and delivery model.
Risks
- Past performance thresholds may require one additional teaming partner.
- Potential clarification needed on staffing minimums before bid/no-bid.
Next steps
Validate eligibility requirements, assign capture owner, and schedule partner outreach to confirm teaming strategy before submission planning.
Quick Summary
The U.S. Food and Drug Administration (FDA) is conducting a Sources Sought market survey to identify vendors capable of providing a Subcutaneous Injection Site Simulator (SCISSOR) system. This system is crucial for regulatory research into complex long-acting injectable drug products. Capability statements are due June 1, 2026, by 2:00 PM CT.
Purpose
This Sources Sought Notice (SSN) is a market survey to gather information from potential vendors regarding their ability to supply an in vitro SCISSOR system. The FDA's Center for Drug Evaluation and Review (CDER), Division of Pharmaceutical Quality Research V (DPQRV), requires this system to develop robust and reliable in vitro methodologies. The goal is to provide alternatives to in vivo pharmacokinetic studies, which are often complex and ethically challenging, enabling the FDA to characterize drug products and establish science-based bioequivalence recommendations.
Scope of Requirements
The FDA seeks a complete, stand-alone SCISSOR instrument system with the following key features:
- Minimum of six (6) independent chambers with individual temperature and flow control.
- Integrated camera or imaging system for real-time monitoring.
- Automated injection system ensuring reproducible sample introduction.
- Optical detection and monitoring for simultaneous spectroscopic analysis.
- Automated fraction collection system with a minimum capacity of 30 vials per chamber.
- Calibration and standardization tools, initial consumables, and accessories.
- Comprehensive software for control and data management.
- Minimum one-year full manufacturer's warranty.
- Complete installation services and comprehensive on-site training for FDA personnel.
- Access to vendor technical support via phone and email.
- Provision of documentation and compliance certificates.
Submission Details
Interested vendors should submit capability statements via email to timothy.walbert@fda.hhs.gov by June 1, 2026, at 2:00 PM Central Time. Responses must detail business information, past performance, descriptive literature, technical information, service capability, GSA Schedule/contract details (if applicable), subcontracting opportunities, warranty, and place of manufacture. Informational pricing is requested but not mandatory. This is a market research notice; no contract will be awarded from this SSN.
Eligibility & Set-Aside
The FDA is particularly interested in small business sources under NAICS Code 334516 (Analytical Laboratory Instrument Manufacturing) with a 1,000-employee size standard. Other than small business concerns are also encouraged to respond.
Contact Information
Primary Point of Contact: Tim Walbert Email: timothy.walbert@fda.hhs.gov Phone: 301-796-1768
Important Notes
Responses containing web links will not be opened. Vendors should avoid including proprietary, classified, confidential, or sensitive information. Comments regarding any restrictive requirements are welcome.