Patient Samples of Medical Device Implantation

Closed Solicitation Posted

Solicitation number
FDARFP03172023
Agency
Responses due
Set-aside
No set-aside

Opportunity facts

Place of performance
Silver Spring, Maryland 20993, United States

Notice details come from SAM.gov. Updated .

About this opportunity

The Food and Drug Administration seeks to award an indefinite delivery/indefinite quantity contract to acquire and analyze patient tissue samples from metal implant devices to characterize immunological and cellular responses and identify specific immune markers expressed. Offerors must submit separate technical and price proposals by April 21, 2023 addressing technical approach, key personnel qualifications, and experience. Evaluation will be based on a best value determination considering technical factors as more important than price.

There is no set-aside designated for this requirement. The NAICS code is 541714 and size standard is 1,000 employees. Performance will take place in Silver Spring, MD over a 12-month period to acquire a statistically significant number of samples from implant recipients and report aggregated data and narrative summaries identifying genomic and molecular markers involved in adverse immune responses to metal alloys. Invoicing will be through the Treasury Department's Invoice Processing Platform system.

Notice text

The Food and Drug Administration (FDA) has a requirement to procure a study to understand how medical implantation alters local and/or systemic immune response relative to implanted metal-allow devices.

See Attachments for RFP detail and Statement of Work.

Files

File Type Posted
RFP FINAL 3 17 2023.pdf PDF
ATTACHMENT 2 IPP INVOICING.pdf PDF
ATTACHMENT 1 STATEMENT OF WORK.pdf PDF

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