

Analytical Framework for Examining the Value of Antibacterial Products. 5.1.3 Clinical Research Costs
Depending upon the characteristics of the diagnostic, manufacturers might be required to perform one or more clinical trials, to obtain data for a 510(k) and data to obtain a CLIA Waiver for POC use. While only a small fraction of 510(k) devices perform any clinical trials, most of the FDA-approved rapid diagnostics for bacterial diseases have c