Inactive

The Department of Veterans Affairs, San Francisco VA Medical Center (SFVA), needs services for regulatory and quality guidance for the submission of a 510(k) application to FDA, which will allow marke... The Department of Veterans Affairs, San Francisco VA Medical Center (SFVA), needs 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. SFVA has developed a new implant for hip replacement surgery. To allow release of this implant for use in patients in the United States, regulatory and quality requirements must be met, for example, to satisfy Food and Drug Administration (FDA) requirements. These requirements will demonstrate the safety of the implant prior to widespread clinical use. SALIENT CHARACTERISTICS: Component Description (Specification) Qty Quality System Quality system, including design control system, that will support application for FDA clearance of the VA femoral implant 1 EA Regulatory System Regulatory system that will support investigational device exemption and 510(k) clearance applications for FDA clearance of the VA femoral component 1 EA 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 Location: San Francisco VAMC 4150 Clement Street San Francisco, CA 94121 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. This is a Sources Sought synopsis only. The purpose of this synopsis is to gain knowledge of potential qualified sources and their size classification (large business, small business, 8(a), SDVOSB, etc.), relative to NAICS code 541714. Responses to this synopsis will be used by the Government to make appropriate acquisition decisions. This notice 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 than no later than Monday, May 16. 2022, 3:00 PM EST. Interest/capability statements may be sent to Rachael Talbott Rachael.Talbott@va.gov with the 36C24E22Q0148 titled in subject box. No telephone responses will be accepted.