FDA Issues Draft Guidance on Establishing Performance Characteristics of Nucleic Acid-Based Diagnostic Devices for MRSA and SA

Strategic Insights -

The Food and Drug Administration (FDA) has announced the availability of a draft guidance document titled "Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA)." The draft guidance aims to provide industry and Agency staff with recommendations for studies to establish the analytical and clinical performance of nucleic acid-based in vitro diagnostic devices (IVDs) intended for the detection and differentiation of MRSA and SA. This guidance is not final and is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115).

Key Takeaways:

  • The draft guidance is intended to provide recommendations for studies to establish the analytical and clinical performance of nucleic acid-based IVDs for the detection and differentiation of MRSA and SA.
  • The guidance does not address detection of MRSA/SA antigens or serological response from the host to the MRSA/SA antigens, nor does it address establishing performance of non-MRSA/SA components of multi-analyte or multiplex devices.
  • The draft guidance is being issued consistent with FDA's good guidance practices regulation (21 CFR 10.115) and will represent the Agency's current thinking on establishing the performance characteristics of nucleic acid-based IVDs for the detection and differentiation of MRSA and SA.
  • The guidance does not create or confer any rights for or on any person and does not operate to bind FDA or the public.
  • Interested persons may submit electronic or written comments on the draft guidance to the Division of Dockets Management by April 5, 2011.

Statistics:

  • The draft guidance is available for public comment until April 5, 2011.
  • The guidance will be reviewed by the FDA and will be final after the public comment period closes.
  • The draft guidance is available online at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm.
  • The document number for the guidance is 1722.

Sources:

  • "Establishing the Performance Characteristics of Nucleic Acid-Based In vitro Diagnostic Devices for the Detection and Differentiation of Methicillin-Resistant Staphylococcus aureus (MRSA) and Staphylococcus aureus (SA)," FDA, Draft Guidance Document (no date listed).
  • 21 CFR 10.115, FDA's good guidance practices regulation.