Clinical Support to Aggregate Patient Data at Patient Care Facilities True Scope of Metal Implant Related Adverse Health Outcomes.

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.