Opportunity
SAM #FDA-RFQ-135363
FDA Solicitation for Portable Aerosol Particle Counter and Validation Materials
Buyer
FDA Office of the Associate General Counsel for Administrative Law
Posted
August 05, 2026
Respond By
August 17, 2026
Identifier
FDA-RFQ-135363
NAICS
334519, 334516
The Food and Drug Administration (FDA), Winchester Engineering and Analytical Center, is soliciting quotes for a newly manufactured Portable Aerosol Particle Counter and related validation materials. - Government Buyer: - Food and Drug Administration (FDA), Winchester Engineering and Analytical Center - Products and Quantities: - 1 Portable Aerosol Particle Counter - Must be newly manufactured - Must meet ISO 17025:2015 compliance - Wireless capability, printer, touch screen interface, USB storage - Compatible with Windows 11 - Compliant with CFR 21 Part 11 - 1 IQ/OQ Validation Manual (Instrument Validation Guide) - 1 Software package (instrument software) - Windows 11 compatible - CFR 21 Part 11 compliant - 1 Software Validation Manual (Validation Guide for software) - Notable Requirements: - Delivery required within 60 days of contract award - 12-month warranty period post-acceptance - All manuals and validation documentation must be included - Equipment must be ISO-compliant and support regulatory testing - No specific OEMs or vendors are named in the solicitation - Firm Fixed Price award to a GSA Federal Supply Schedules Contractor
Description
The Food and Drug Administration (FDA) requires a new Portable Aerosol Particle Counter to support regulatory testing.