FDA upper limb prosthesis system w/TASKA hand

The FDA Office of Acquisition and Grant Services seeks a complete, fully assembled bypass upper limb prosthetic system with a TASKA CX or equivalent terminal hand, with quotes due August 25, 2026. This is a total small business set-aside; only small businesses actively registered in SAM.gov may quote.

Place of performance is the United States, with FOB Destination to FDA-CDRH in Silver Spring, Maryland. The NAICS code is 339113, Surgical Appliance and Supplies Manufacturing, with a small business size standard of 750 employees.

The procurement requires a single unit designed for research and simulation to allow non-amputee users to operate prosthetic systems. Key technical specifications include a 7-inch myoelectric hand with independently articulating digits, lateral and rotational compliance, IP67 water resistance, electronically multi-positional thumb, wrist flexion capability, and 2-site proportional programmable control with removable suction EMG electrodes integrated into a carbon fiber socket with removable forearm shell. The system must include staff familiarization and maintenance training, an option to transition to pattern recognition control, a one-year full hardware warranty from government acceptance, and a two-year full manufacturer's warranty from FDA acceptance with all shipping costs included. Offerors must provide sufficient technical documentation demonstrating compliance with all minimum technical requirements, including descriptive materials and brochures.

The contract is Firm Fixed-Price. Payment terms are Net 30 days after government acceptance, with invoices submitted electronically through the Treasury's Invoice Processing Platform. The offer must remain firm through September 30, 2026. Award will be made to the lowest-priced technically acceptable and responsible offeror. Questions should be directed to timothy.walbert@fda.hhs.gov.