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Antimicrobial Susceptibility Test-Makers Seek Ways To Shorten FDA Clearance Process

 
• By Sue Darcey

A group of antimicrobial susceptibility test manufacturers are working with US FDA regulators to hasten the clearance process for their products. The agency recent convened a workshop at its Maryland headquarters to help address the issue.

Manufacturers of antimicrobial susceptibility diagnostics want US FDA to revise definitions for strains of microbes used to validate their tests and make other adjustments to how test data is assessed to speed the development process for susceptibility assays.

An industry coalition forwarded such proposals during a Sept. 13 workshop convened by US FDA on antimicrobial susceptibility.

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