Packaging, Labeling, and Sterilization Services

The contract requires the provision of medical-grade packaging, sterilization using ethylene oxide or gamma irradiation, and FDA-compliant labeling including a Unique Device Identifier for the Clitoral Therapy Device. All services must meet stringent regulatory standards to ensure product safety, efficacy, and traceability in compliance with U.S. Food and Drug Administration requirements. The work is classified as a subcontract under NAICS code 811212 and is being managed by the Strategic Acquisition Center Fredericksburg under the Department of Veterans Affairs. Responses are due by January 6, 2026, with performance expected to align with federal medical device regulations and quality control protocols for clinical use. The packaging must protect the device from contamination and degradation throughout its lifecycle while enabling safe handling and storage. Sterilization processes must be validated and documented to confirm the elimination of microbial contamination without compromising device integrity. Labeling must contain all FDA-mandated information, including the UDI, expiration date, lot number, manufacturer details, and usage instructions in legible and durable format. The successful contractor will be responsible for maintaining full compliance with applicable FDA 21 CFR Part 820 and ISO 13485 standards, ensuring every step from packaging through labeling is auditable and traceable under quality management systems.