DRAFT GUIDANCE
This guidance document is being distributed for comment purposes only.
Document issued on: June 15, 2011
You should submit comments and suggestions regarding this draft document within 90 days of publication in the Federal Register of the notice announcing the availability of the draft guidance. Submit written comments to the Division of Dockets Management (HFA-305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852. Submit electronic comments to http://www.regulations.gov. Identify all comments with the docket number listed in the notice of availability that publishes in the Federal Register.
For questions regarding this document contact Alexandra Wong at 301-796-6210 or by email at [email protected].
U.S. Department of Health and Human Services
Food and Drug Administration
Center for Devices and Radiological Health
Office of In Vitro Diagnostic Device Evaluation and Safety
Division of Microbiology Devices
Preface
Additional Copies
Additional copies are available from the Internet. You may also send an e-mail request to [email protected] to receive an electronic copy of the guidance or send a fax request to 301-827-8149 to receive a hard copy. Please use the document number 1729 to identify the guidance you are requesting.
Table of Contents
- Introduction
- Background
- Scope
- Device Description
- Risks to Health
- Establishing Performance Characteristics for Culture Methods
- Controls
- Performance Studies
- CLIA Waiver
- References
Draft Guidance for Industry and FDA Staff
Establishing the Performance Characteristics of In Vitro Diagnostic Devices for the Detection of methicillin-resistant Staphylococcus aureus (MRSA) for Culture Based Devices
This draft guidance, when finalized, will represent the Food and Drug Administration’s (FDA’s) current thinking on this topic. It does not create or confer any rights for or on any person and does not operate to bind FDA or the public. You can use an alternative approach if the approach satisfies the requirements of the applicable statutes and regulations. If you want to discuss an alternative approach, contact the FDA staff responsible for implementing this guidance. If you cannot identify the appropriate FDA staff, call the number listed on the title page of this guidance.
I. Introduction
FDA is issuing this draft guidance to provide industry and agency staff with recommendations for studies to establish the analytical and clinical performance of in vitro diagnostic devices (IVDs) intended for the detection of methicillin-resistant Staphylococcus aureus (MRSA) using culture based methods . These devices are used to aid in the prevention and control of MRSA infections in healthcare settings.
This guidance provides detailed information on the types of studies FDA recommends in order to support Class II premarket submissions for these devices. The guidance includes examples of MRSA strains recommended for analytical sensitivity and inclusivity studies and examples of microorganisms recommended for analytical specificity studies.
This document is limited to studies intended to establish the performance characteristics of devices that detect MRSA by growth in culture media or those devices that test for the protein, penicillin-binding protein 2a (PBP2a or PBP2′), expressed by the mecA gene. This includes culture-based devices that use selective or chromogenic media. The document does not address the detection of serological response from the host to the MRSA antigens, nor does it address establishing the performance of non-MRSA components of multi-analyte or multiplex nucleic acid based devices.
FDA’s guidance documents, including this guidance, do not establish legally enforceable responsibilities. Instead, guidances describe the Agency’s current thinking on a topic and should be viewed only as recommendations, unless specific regulatory or statutory requirements are cited. The use of the word should in Agency guidances means that something is suggested or recommended, but not required.
Premarket Notification 510(k).” Guidance on the content and format for abbreviated and traditional 510(k) s is available in the guidance entitled “Format for Traditional and Abbreviated 510(k)s.”
Further information on device testing can be found in the guidance entitled “In Vitro Diagnostic (IVD) Device Studies – Frequently Asked Questions,” and the guidance entitled “Guidance on Informed Consent for In Vitro Diagnostic Device Studies Using Leftover Human Specimens that are Not Individually Identifiable.”
Recommendations for Clinical Laboratory Improvement Amendments of 1988 (CLIA) Waiver Applications for Manufacturers of In Vitro Diagnostic Devices.”
1 See 42 U.S.C. § 263a(d)(3).
Guidance for Industry and FDA: Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems.