Procurement of Benchtop Environmental Temp/Humidity Chamber

Notice of Combined Synopsis/Solicitation. This is a combined synopsis/solicitation for commercial products or commercial services prepared in accordance with part 12.

This announcement constitutes the only solicitation; quotes are being requested, and a separate written solicitation will not be issued. The NAICS for this requirement is: 334516. The government is not obligated to make an award.

The Government is not obligated to pay costs incurred by the Contractor during quote preparation and quote submission.

Background: The FDA laboratory at the Winchester Engineering Analytical Center (WEAC) uses an environmental chamber to condition regulatory samples (such as tampons, gowns, patches, etc.) at specific temperature and humidity levels before physical testing. The chamber also supports CDRH-directed research and test method development for other medical devices received by the laboratory for analysis.

Minimum Performance Requirements/Salient Characteristics: This is a Brand Name or Equal requirement. Products other than the aforementioned are acceptable but shall meet all the salient characteristics contained in the Minimum Technical Requirements below: All of the following system requirements are minimum requirements. Equivalent requirements that differ from these minimum requirements shall be justified by the proposing vendor and evaluated by the WEAC prior to purchase: General The contractor shall provide an environmental chamber that uniformly conditions samples across a variety of temperature and humidity settings.

The chamber must meet the following specifications: Temperature range: at least -20C to 180C Humidity range: 10% to 95% relative humidity (RH) Capacity: 4 cu. Ft.

Power: Standard power cord and plug (no hardwiring) Water supply: Easily accessible water supply connection Humidity sensor: Solid-state humidity sensor Leak Detection: Must have a water leak containment and detection system Viewing window: For visual monitoring of samples Interior shelf: At least one internal shelf Mobility: Mobile cart with space-saving footprint (lab has no bench space and limited floor space for the chamber) Cable port: At least one 2-inch diameter cable port with a flexible plug Calibration: Factory calibration with an ISO 17025 certificate, or instrument calibration at start-up with ISO 17025 certificate Warranty: At least one year On-site Installation, Training and Commissioning On-site installation and commissioning of the Environmental Chamber Trade and Service Specification All components shall be newly manufactured, not used or refurbished, and/or previously used for demonstration. System installation shall occur after being received at the laboratory. The entire system shall be warranted for parts and labor for a minimum of 12 months from date of formal government acceptance after on-site installation.

The warranty must include unlimited telephone/e-mail support for questions regarding operation.

Additional Section 508 Requirements: Must meet WCAG 2.0 A and AA E101.2 Equivalent Facilitation (Appendix A, Application and Scoping Requirements) E203 Access to Functionality (Appendix A, Application and Scoping Requirements) E204 Functional Performance Criteria (Appendix A, Application and Scoping Requirements) E205 Electronic Content (Appendix A, Application and Scoping Requirements) 302 Functional Performance Criteria (Appendix C, Functional Performance Criteria and Technical Requirements) Electronic content must be accessible to HHS acceptance criteria. Checklist for various formats are available at https://www.hhs.gov/web/section-508/making-files- accessible/index.html, or from the Section 508 Coordinator listed at https://www.hhs.gov/web/section-508/additional- resources/section-508- contacts/index.html. Materials that are final items for delivery should be accompanied by the appropriate checklist, except upon approval of the Contracting Officer or Representative.

E208 Support Documentation and Services (Appendix A, Application and Scoping Requirements) Chapter 6 Support Documentation and Services (Appendix C, Functional Performance Criteria E206 Hardware (Appendix A, Application and Scoping Requirements) Chapter 4 Hardware (Appendix C, Functional Performance Criteria and Technical Requirements) and Technical Requirements) E207 Software (Appendix A, Application and Scoping Requirements) Chapter 5 Software (Appendix C, Functional Performance Criteria and Technical Requirements) Place of Performance: The prospective vendor should provide insured shipping of equipment to: U.S. Food and Drug Administration, Winchester Engineering and Analytical Center (WEAC) Office of Specialty Laboratories and Enforcement Support 109 Holton Street Winchester, MA 01890 Period of Performance: Performance begins on the date of formal government acceptance and continues through the end of the manufacturer's warranty period. Quotes are due by email on or before September 25 2026, by 12:00 P.M.

(Eastern Standard Time) and should be sent to [email on the source notice].