FDA Offers Guidance for MRSA Diagnostic Devices

The draft guidance recommends studies for establishing the devices' performance characteristics, to aid in preventing and controling infections in health care settings.

New draft guidance out from the U.S. Food and Drug Administration offers assistance to industry and FDA's staff on studies that would establish performance characteristics for in vitro diagnostic devices that will help to prevent and control MRSA infections in health care settings.

The draft, titled "Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Methicillin-Resistant Staphylococcus Aureus for Culture-Based Devices," also covers studies for the detection or detection and differentiation of MRSA versus S. aureus in either human specimens or bacterial growth detected by continuous monitoring blood culture systems. The draft guidance is not final and is not yet in effect. Comments (Docket No. FDA-2011-D-0378, www.regulations.gov) are due by Sept. 13.

The draft covers only studies intended to establish the performance characteristics of devices that detect MRSA by growth in culture media or that test for the penicillin-binding protein 2a (PBP2a or PBP2'), expressed by the mecA gene. The Federal Register notice was signed by Nancy K. Stade, deputy director for Policy at the Center for Devices and Radiological Health.

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    January 2019

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