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U.S. Department of Health and Human Services

Recognized Consensus Standards
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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 043 Date of Entry 06/27/2016 
FR Recognition Number 7-264
Standard
CLSI MM21-1st Edition (Reaffirmed: January 2020)
Genomic Copy Number Microarrays for Constitutional Genetic and Oncology Applications
Scope/Abstract
This guideline provides recommendations for validation, verification, performance, and interpretation of nucleic acid microarrays used for cytogenetic applications to measure copy number imbalances and loss of heterozygosity. Both constitutional and oncology applications are addressed.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Sub-Section 2.3.4.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§866.5920 System, Microarray-Based, Genome-Wide, Postnatal Chromosomal Abnormality Detection Class 2 PFX
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
 Sharon (Xueying) Liang
  FDA/OMPT/CDRH/OIR/DMGP/MGB/
  301-796-9601
  sharon.liang@fda.hhs.gov
 Karen Bijwaard
  FDA/OC/CDRH/OPEQ/OIDRH/DMGP/MPCB/
  301-796-6162
  karen.bijwaard@fda.hhs.gov
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.
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