Clinical Support to Aggregate Patient Data at Patient Care Facilities True Scope of Metal Implant Related Adverse Health Outcomes.
Closed Solicitation Posted
- Solicitation number
- FDA-RFP-2021-1243291
- Agency
-
FDA Office of Acquisition and Grant Services
Food and Drug Administration, Department of Health and Human Services
- Responses due
- Set-aside
- Total Small Business
Opportunity facts
- NAICS code
- 541715 Research and Development in the Physical, Engineering, and Life Sciences (except Nanotechnology and Biotechnology)
- PSC
- Q999 Medical- Other
- Place of performance
- Silver Spring, Maryland 20907, United States
Notice details come from SAM.gov. Updated .
About this opportunity
The Food and Drug Administration seeks to award a firm fixed-price contract for clinical support services to aggregate patient data from multiple healthcare facilities. The goal is to analyze potential adverse health outcomes related to metal-containing implantable medical devices. Services will include collecting demographic, clinical, and epidemiological real-world data on patients with metal implants or non-metal counterparts as controls. Proposals are due by September 3, 2021 and will be evaluated based on technical approach, relevant experience, and pricing.
This requirement is set aside for small businesses only and has a North American Industry Classification System code of 541715 for research and development services. The contract has a one-year base period to analyze data for cardiovascular and other implant categories, with an option to extend work to additional device types in year two. Services will involve collaborating with the FDA to define implant categories and obtain required data from multiple sources over 12 months initially. A third-party auditor will validate any necessary data.
Notice text
This is a combined synopsis/solicitation for commercial items prepared in accordance with the format in Subpart 12.6, as supplemented with additional information included in this notice. This announcement constitutes the only solicitation. Quotes are being requested and a written solicitation will not be issued.
Solicitation Number # FDA-RFP-2021-1243291 and incorporated provisions and clauses are those in effect through Federal Acquisition Circular (FAC 2021-06). This requirement is being solicited as a total small business set-aside 100% (for small businesses only) using the Simplified Acquisition Procedures per FAR Subpart 13.5.
The Government intends to award a Firm Fixed-Price (FFP) Contract, to procure the requested Clinical Support to Aggregate Patient Data at Patient Care Facilities True Scope of Metal Implant Related Adverse Health Outcomes.
The FDA Center for Devices and Radiological Health (CDRH) ensures that patients and providers have timely and continued access to safe, effective, and high-quality medical devices and radiation-emitting products. CDRH provides consumers, patients, their caregivers, and providers with comprehensible and accessible science-based information about the products it oversees. CDRH facilitates medical device innovation by advancing regulatory science, providing industry with predictable, consistent, transparent, and efficient regulatory pathways, and assuring consumer confidence in devices marketed in the U.S.
Following the Center’s public health mandate regarding safety of medical devices, the main objective of this healthcare data acquisition is to analyze adverse health outcomes that may result from the use of metal-containing implantable devices (metal implants). This effort requires collation of patient- and device-related information using real-world data (RWD) from multiple healthcare facilities and other available sources. The gathered demographic, clinical, and epidemiological RWD regarding patients with metal implants (or their non-metal counterparts as controls) will be analyzed in relation to corresponding device/ material characteristics, in order to further improve health outcomes in patients with metal implants.
Files
| File | Type | Posted |
|---|---|---|
| FDA-RFP-2021-1243291_Amend1.pdf | ||
| QuestionResponses.docx | DOCX document | |
| FDA 1335.docx | DOCX document | |
| FDA-RFP-2021-1243291.pdf |
Similar open opportunities
| Opportunity | Agency | Set-aside | Responses due |
|---|---|---|---|
| FDA/CDRH Scientific Technical Capacity for Regulatory Review | FDA Office of Acquisition and Grant Services | No set-aside | |
| FDA Scientific & Regulatory Support Services(SRS) | FDA Office of Acquisition and Grant Services | Total Small Business |
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