AN21--Sole Source Notice: Remedy Medical, LLC Quality and regulatory services includes meeting FDA requirements for 510(k) clearance of femoral components for total hip arthroplasty

The San Francisco Veterans Affairs Medical Center (SFVA) intends to negotiate on a sole source basis, pursuant to FAR 13.106-1, for quality and regulatory services that will satisfy FDA requirements for 510(k) clearance of femoral components for total hip arthroplasty with Remedy Medical, LLC. These services will occur from 2022 to 2024 with general specifications for regulatory and quality services 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. This is for support of a novel hip replacement implant developed by the SFVA. The selected firm must be able to provide quality and regulatory services that will satisfy FDA requirements for 510(k) clearance of femoral components for total hip arthroplasty.

Specifications

The quality and regulatory specifications to allow successful FDA clearance of the VA implant will include the following:

Regulatory

Draft pre-submission regarding testing protocols and submit to FDA for

written feedback

Review feedback from FDA and review with San Francisco VA

IDE Submission to FDA

IDE Submission to FDA, including review of protocols

510(k) Submission

Draft 510(k)

Response to rounds of questions for 510(k)

Quality Management System

Establish Design Controls

Establish & Implement Document & Record Controls

Establish supplier Controls

Establish production Controls

Establish & Implement Investigation, Risk Assessment, Analysis & Decision

Resource Management, Continuous Improvement, Work Environment, Infrastructure, Handling, Storage & Distribution

The C&A requirements do not apply, and that a Security Accreditation Package is not required.

Delivery Requirements:

The Vendor shall notify SFVA of the delivery dates for each component of the quality and regulatory systems. This notification shall be provided at least one month prior to the vendor-anticipated delivery date.

Delivery Location:

San Francisco VAMC

4150 Clement Street

San Francisco, CA 94121

This notice of intent is not a request for competitive proposals; however, any responsible source who believes it is capable of meeting the requirement and who is the Original Equipment Manufacturer (OEM), authorized dealer, authorized distributor or authorized reseller of all the items listed above, may submit a capability statement to the contracting office no later than Friday, April 22, 2022, 4:00 PM, EST, with the descriptions in detail how the vendor can meet or exceed the Veterans Affairs requirements. Submit required information to Rachael.Talbott@va.gov; with the subject titled: 36C24E22Q0111. 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.