The FDA Review Criteria for Assessment of Antimicrobial Susceptibility Devices — Too Much or Not Enough Regulation?

Abstract

The Medical Device Law of 1976 provided specific regulations for use by the Food and Drug Administration (FDA) in the evaluation of substantial equivalency and safety and effectiveness of medical devices, including in vitro diagnostic devices such as antimicrobial susceptibility testing systems, prior to clearance for market release. As technology progressed through the years, the FDA continued to refine the requirements used in their evaluation of new devices to insure that each new technological advance was thoroughly tested prior to market introduction. Recently, the FDA Office of Device Evaluation published a document entitled, “Review Criteria for Assessment of Antimicrobial Susceptibility Devices”.¹ This document details the FDA recommendations for the type of clinical testing a manufacturer should perform; the way data should be presented to the FDA; and the minimal performance characteristics of a new system. These new review criteria will be discussed along with their potential implications for the manufacturers of Antimicrobial Susceptibility Test(AST) devices.