SOLICITATION NOTICE
A -- INTENT TO SOLE SOURCE
- Notice Date
- 5/24/2022 1:12:51 PM
- Notice Type
- Presolicitation
- NAICS
- 541714
— Research and Development in Biotechnology (except Nanobiotechnology)
- Contracting Office
- RPO EAST (36C24E) PITTSBURGH PA 15212 USA
- ZIP Code
- 15212
- Solicitation Number
- 36C24E22Q0157
- Response Due
- 5/27/2022 9:00:00 AM
- Archive Date
- 06/26/2022
- Point of Contact
- Rachael Talbott, Contract Specialist
- E-Mail Address
-
Rachael.Talbott@va.gov
(Rachael.Talbott@va.gov)
- Awardee
- null
- 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.
- Web Link
-
SAM.gov Permalink
(https://sam.gov/opp/3c71695841094341b0640d38df757946/view)
- Place of Performance
- Address: San Francisco VAMC 4150 Clement Street, San Francisco 94121, USA
- Zip Code: 94121
- Country: USA
- Zip Code: 94121
- Record
- SN06336365-F 20220526/220524230119 (samdaily.us)
- Source
-
SAM.gov Link to This Notice
(may not be valid after Archive Date)
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