• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

Recognized Consensus Standards

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

New Search Back To Search Results
Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 030 Date of Recognition 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
§864.7280 Test, Factor V Leiden Mutations, Genomic Dna Pcr Class 2 NPQ
§862.3360 Drug Metabolizing Enzyme Genotyping Systems Class 2 NTI
Unclassified Assay, Hybridization And/Or Nucleic Acid Amplification For Detection Of Hepatitis C Rna,Hepatitis C Virus Class 3 MZP
Relevant FDA Guidance and/or Supportive Publications
There is no relevant guidance developed at this time.
FDA Technical Contacts
 Francisco Martinez-Murillo
  FDA/OMPT/CDER/OND/ODEIV/DNDP/
  301-796-6201
  francisco.martinez@fda.hhs.gov
 Rosalie Elespuru
  FDA/OMPT/CDRH/OSEL/DBCMS/
  301-796-0237
  rosalie.elespuru@fda.hhs.gov
Standards Development Organization
CLSI Clinical Laboratory Standards Institute https://clsi.org/
FDA Specialty Task Group (STG)
InVitro Diagnostics
-
-