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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 021 Date of Entry 03/18/2009 
FR Recognition Number 7-192
CLSI  MM18-A (Replaces MM18-P)
Interpretive Criteria for Indentification of Bacteria and Fungi by DNA Target Sequencing; Approved Guideline
This guideline includes information on sequencing DNA targets of cultured isolates, provides a quantitative metric for perceiving microbial diversity, and can serve as the basis to identify microorganisms. By establishing interpretive criteria for microorganism identification by targeted DNA sequencing, this guideline provides structure to laboratories that identify microorganisms for medical use.
Extent of Recognition
Complete standard
Relevant FDA Guidance and/or Supportive Publications*
Nucleic Acid Based in Vitro Diagnostic Devices for Detection of Microbial Pathogens - Draft Guidance for Industry and FDA Staff

Review Criteria for Nucleic Acid Amplification Based In Vitro Diagnostic Devices for Direct Detection of Infectious Microorganisms

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
 Faiza Benahmed
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.