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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 041 Date of Entry 04/04/2016 
FR Recognition Number 7-260
CLSI  MM03-3rd Edition (Replaces MM03-A2)
Molecular Diagnostic Methods for Infectious Diseases; Approved Guideline
This document provides recommendations for cytology laboratories to use in developing preexamination, examination, and postexamination processes and procedures for nongynecological cytology specimen management.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.3120 Dna-Reagents, Chlamydia Class 1 LSK
§866.3120 Dna Probe, Nucleic Acid Amplification, Chlamydia Class 1 MKZ
§866.3370 Dna-Reagents, Mycobacterium Spp. Class 1 LQF
§866.3390 Dna-Reagents, Neisseria Class 2 LSL
Relevant FDA Guidance and/or Supportive Publications*
Draft Guidance for Industry and FDA Staff Nucleic Acid Based In Vitro Diagnostic Devices for Detection of Microbial Pathogens, Issued December 2005.

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
 Li Li
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.