The FDA Review Criteria for Assessment of Antimicrobial Susceptibility Devices — Too Much or Not Enough Regulation?
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.
KeywordsMinimum Inhibitory Concentration Antimicrobial Susceptibility Antimicrobial Susceptibility Test Major Error Categorical Agreement
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- 1.Review Criteria for Assessment of Antimicrobial Susceptibility Devices, Food and Drug Administration (May, 1991).Google Scholar
- 2.National Committee for clinical Laboratory Standards Approved Standard M2-A4, Performance Standard for Antimicrobial Disk Susceptibility Tests, Fourth Edition, NCCLS, Villanova, PA (1990).Google Scholar
- 3.National Committee for Clinical Laboratory Standards Approved Standard M7-A2, Methods for Dilution Antimicrobial Susceptibility Tests for Bacteria that Grow Aerobically, Second Edition, NCCLS, Villanova, PA (1990).Google Scholar
- 4.National Committee for Clinical Laboratory Standards, Tentative Guideline, M23-T, Development of in vitro Susceptibility Testing Criteria and Quality Control Parameters, NCCLS, Villanova, PA (1989).Google Scholar
- 5.G.L. Mandel, R.G. Douglas, and J.E. Bennett, Principals and Practices of Infectious Diseases, 3rd Edition, Churchill Livingston, New York, pp. 218–349 (1990).Google Scholar
- 6.J.O. Yao, R.C. Moellering, Antimicrobial Agents, In: “Manual of Clinical Microbiology”, 5th Edition, ASM, Washington, D.C. 1065–1098 (1991).Google Scholar
- 7.Physicians Desk Reference, 45th Edition, Medical Economics Company, Oradell, New Jersey (1991).Google Scholar
- 9.J.C. Sherris, and K.J. Ryan, Evaluation of Automated and Rapid Methods, in “Rapid Methods and Automation in Microbiology”, R.G Tilton, ed., ASM, Washington, D.C. (1982).Google Scholar