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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 053 Date of Entry 12/23/2019 
FR Recognition Number 7-295
CLSI  M52, 1st ed. August 2015 (Reaffirmed: January 2020)
Verification of Commercial Microbial Identification and Antimicrobial Susceptibility Testing Systems.
This guideline provides recommendations for clinical laboratory professionals for verification of commercial microbial identification systems (MIS) and US Food and Drug Administration (FDA)-cleared antimicrobial susceptibility testing systems (ASTS) to fulfill regulatory or QA requirements for use in diagnostic testing. Recommendations for postverification QA are also included. This guideline focuses on instrument-based systems commonly used in clinical laboratories, but the recommendations may also be applicable to manual methods for microbial identification (ID) and antimicrobial susceptibility testing (AST), including disk diffusion and gradient diffusion strips.

This guideline is not intended to provide guidance to manufacturers of in vitro diagnostic devices. A manufacturer must perform many studies during the research and development phases and the manufacturing validation phase that are unique to the design of the test system and the manufacturing processes. These studies go beyond the scope of this document. See Appendix A for a description of the FDA requirements for MIS and ASTS clearance.
Extent of Recognition
Complete standard
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.1640 Antimicrobial susceptibility test powder.
§866.1645 Fully automated short-term incubation cycle antimicrobial susceptibility system.
Relevant FDA Guidance and/or Supportive Publications*
Class II Special Controls Guidance Document: Antimicrobial Susceptibility Test (AST) Systems, Issued August 28, 2009.

Appropriate Use of Voluntary Consensus Standards in Premarket Submissions for Medical Devices - Guidance for Industry and Food and Drug Administration Staff, issued September 2018.
FDA Technical Contact
 Natasha Griffin
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
*These are provided as examples and others may be applicable.