AN21--intent to sole source

The Department of Veterans Affairs, San Francisco VA (SFVA) Medical Center (SFVA), intends to negotiate on a sole source basis, pursuant to FAR 6.302-1, with Remedy Medical, LLC. Investigators at the SFVA are seeking services for regulatory and quality guidance for the submission of a 510(k) application to FDA, which will allow marketing of the VA-designed implant in the United States. This will include review of testing protocols, submission of an Investigational Device Exemption (IDE) as well as a submission of a 510(k) application. The company must have prior experience in orthopedic regulatory action and specifics for orthopedic device quality systems.Â

This notice of intent is not a request for competitive proposals; however, any responsible source who believes it is capable of meeting the requirement may submit a capability statement to the contracting office no later than Friday, May 27, 2022, 12:00, EST. Interest/capability statements may be sent to Rachael Talbott at Rachael.Talbott@va.gov. No telephone responses will be accepted. A determination not to compete the proposed requirement based upon the responses to this notice is solely within the discretion of the Government.