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Pharmaceutical industry

FDA Draft Guidance for In Vitro Diagnostic Devices for MRSA Detection

Strategic Insights

— 2 min read

The Food and Drug Administration (FDA) is issuing a draft guidance for industry and Agency staff on the establishment of performance characteristics for in vitro diagnostic devices designed to detect methicillin-resistant Staphylococcus aureus (MRSA). This draft guidance is intended to provide recommendations for studies aimed at establishing the performance characteristics of these devices, including those that detect or differentiate MRSA from S. aureus in human specimens or bacterial growth detected by continuous monitoring blood culture systems.

Key Takeaways:

  • The draft guidance provides recommendations for studies to establish the performance characteristics of in vitro diagnostic devices for the detection of MRSA, including devices that detect or differentiate MRSA versus S. aureus.
  • The guidance focuses on culture-based devices that use selective or chromogenic media, but does not address the detection of serological response from the host to MRSA antigens or establish the performance of non-MRSA components of multianalyte or multiplex nucleic acid-based devices.
  • The draft guidance is not final and is not in effect at this time, but comments can be submitted until September 13, 2011.
  • The FDA is issuing this draft guidance consistent with its good guidance practices regulation (21 CFR 10.115).
  • The draft guidance will represent the Agency's current thinking on establishing the performance characteristics of in vitro diagnostic devices for the detection of MRSA for culture-based devices.
  • Electronic access to the guidance is available at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm or http://www.regulations.gov.
  • Persons interested in obtaining a copy of the draft guidance can do so by sending an e-mail request to dsmica@fda.hhs.gov or sending a fax request to 301-847-8149.

Statistics:

  • September 13, 2011, is the deadline for submitting comments on the draft guidance.
  • The draft guidance is available online at http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/default.htm or http://www.regulations.gov.
  • 10903 New Hampshire Ave., Bldg. 66, rm. 4613, Silver Spring, MD 20993-0002 is the address for submitting written requests for single copies of the draft guidance document.
  • 301-796-6210 is the phone number for further information.

Sources:

  • Food and Drug Administration. (Draft Guidance). "Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of Methicillin-Resistant Staphylococcus Aureus for Culture-Based Devices."
  • 21 CFR 10.115 (Good Guidance Practices Regulation)
  • 21 CFR part 807, subpart E (Device Reporting Requirements)
  • 21 CFR part 812 (Investigational Device Exemption)
  • 21 CFR part 801 and 21 CFR 809.10 (Labeling Requirements)
  • 42 CFR 493.15 (Clinical Laboratory Improvement Amendments)

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