36C24E22Q0157.docx
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- AN21--INTENT TO SOLE SOURCE Federal contract opportunity
- Solicitation number
- 36C24E22Q0157
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Presolicitation Notice Presolicitation Notice
| SUBJECT* |
| INTENT TO SOLE SOURCE |
GENERAL INFORMATION
| CONTRACTING OFFICE’S ZIP CODE* |
| 15212-5319 |
| SOLICITATION NUMBER* |
| 36C24E22Q0157 |
| RESPONSE DATE/TIME/ZONE |
| 05-27-2022 12:00pm EASTERN TIME, NEW YORK, USA |
| ARCHIVE |
| 30 DAYS AFTER THE RESPONSE DATE |
SET-ASIDE
| PRODUCT SERVICE CODE* |
| AN21 |
| NAICS CODE* |
| 541714 |
PLACE OF PERFORMANCE
San Francisco VAMC
4150 Clement Street
San Francisco CA
| POSTAL CODE |
| 94121 |
| COUNTRY |
| USA |
CONTACT INFORMATION
| CONTRACTING OFFICE ADDRESS |
| US Department of Veterans Affairs |
Veterans Health Administration Regional Procurement Office (RPO) East 323 North Shore Drive, Suite 500 Pittsburgh PA 15212-5319
POINT OF CONTACT*
Contract Specialist Rachael Talbott Rachael.Talbott@va.gov
ADDITIONAL INFORMATION
AGENCY’S URL
URL DESCRIPTION
AGENCY CONTACT’S EMAIL ADDRESS
EMAIL DESCRIPTION
DESCRIPTION
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.
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.
| *=Required Field |
| Presolicitation Notice |
Presolicitation Notice
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