Inactive Total Small Business Set-Aside (FAR 19.5)

The U. S. Food and drug Administration (FDA), has a requirement for Clinical Support to Aggregate Patient Data at Patient Care Facilities True Scope of Metal Implant Related Adverse Health Outcomes.Th... The U. S. Food and drug Administration (FDA), has a requirement for Clinical Support to Aggregate Patient Data at Patient Care Facilities True Scope of Metal Implant Related Adverse Health Outcomes.The objective of this acquisition is to identify the true scope of metal-implant related adverse health outcomes. The effort will require multiple sources of demographic, clinical and epidemiological Real-World Data (RWD) on adverse outcomes in relation to device/material characteristics. CDRH expects to explore correlations between patient characteristics and sequalae resulting from metal-associated computability issues in specific patient subpopulations - revealing the true nature and frequency of device-related adverse outcomes. See attached solicitation and respond.