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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 030 Date of Entry 01/15/2013 
FR Recognition Number 7-237
CLSI  MM01-A3 (Replaces MM01-A2)
Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline - Third Edition
This document provides general recommendations for all phases of the operation of a molecular genetics diagnostic laboratory. Clinical molecular testing has application to inherited and acquired medical conditions with genetic etiologies as well as variations associated with drug metabolism. In a clinical molecular laboratory, techniques and practices require strict adherence to quality performance measures. This revised guideline will address the total testing process.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§862.3360 Drug Metabolizing Enzyme Genotyping Systems Class 2 NTI
§864.7280 Test, Factor V Leiden Mutations, Genomic Dna Pcr Class 2 NPQ
§866.3170 Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus Class 2 MZP
Relevant FDA Guidance and/or Supportive Publications*
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 Contacts
 Francisco Martinez-Murillo
 Rosalie Elespuru
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.