Medical Equipment Regulatory Compliance & FDA Clearance Support

The contract seeks regulatory strategy and documentation support to secure FDA clearance for wheelchairs, focusing on proper classification and the preparation of all necessary submissions. The scope includes navigating FDA requirements to ensure compliance with medical device regulations, with an emphasis on accurate classification under applicable device categories and the compilation of technical, clinical, and labeling documentation required for submission. The work is critical to enabling timely market access for wheelchair products within the U.S. healthcare system. This subcontract is issued by the Department of Veterans Affairs through the 262-NETWORK Contract Office 22, with performance expected to take place in Loma Linda, California, at the zip code 92357. It was posted on July 31, 2026, with a response deadline of August 10, 2026, and falls under NAICS code 541690 for other scientific and technical consulting services. The effort supports the VA’s mission to provide accessible and compliant medical equipment for veterans, requiring a firm understanding of federal regulatory frameworks and experience with FDA submissions for Class II medical devices.