FDA Extends Comment Period for Infectious Disease Diagnostic Guidance

The FDA has extended the comment period from Aug. 11 to Sept. 12 for its draft guidance on infectious disease next-generation sequencing diagnostic devices.

Released May 13, the guidance spells out how the agency plans to regulate diagnostics that detect infectious disease organisms, antimicrobial resistance and virulence markers.

Tagged as Class II devices, the FDA will regulate infectious disease NGS diagnostic devices based on a “one-system” approach, similar to the way it regulates molecular-based diagnostic devices.