Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

030

Date of Entry 01/15/2013

FR Recognition Number

7-237

Standard

CLSI MM01-A3 (Replaces MM01-A2)
Molecular Methods for Clinical Genetics and Oncology Testing; Approved Guideline - Third Edition

Scope/Abstract

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

Karen Bijwaard

FDA/OC/CDRH/OPEQ/OHTVII/DMGP/

301-796-6162

karen.bijwaard@fda.hhs.gov

Francisco Martinez-Murillo

FDA/OC/CDER/OC/OUDLC/DLRUD/

301-796-6201

francisco.martinez@fda.hhs.gov

Standards Development Organization

CLSI

Clinical Laboratory Standards Institute