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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 025 Date of Entry 10/04/2010 
FR Recognition Number 7-212
Standard
CLSI EP18-A2
Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition
Scope/Abstract
This guideline describes risk management techniques that will aid in identifying, understanding, and managing sources of failure (potential failure modes) and help to ensure correct results. Although intended primarily for in vitro diagnostics, this document will also serve as a reference for clinical laboratory managers and supervisors who wish to learn about risk management techniques and processes.
Extent of Recognition
Complete standard
Public Law, CFR Citation(s) and Procode(s)*
21 CFR 862 CLINICAL CHEMISTRY AND CLINICAL TOXICOLOGY DEVICES
21 CFR 864 HEMATOLOGY AND PATHOLOGY DEVICES
21 CFR 866 IMMUNOLOGY AND MICROBIOLOGY DEVICES
Relevant FDA Guidance and/or Supportive Publications*
Guidance for Over-the-Counter (OTC) Human Chorionic Gonadotropin (hCG) 510(k)s, Issued July 2000.

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
 Leslie Landree
  FDA/OC/CDRH/OPEQ/OIDRH/DCTD/DB/
  301-796-6147
  leslie.landree@fda.hhs.gov
 Stefanie Akselrod
  FDA/OC/CDRH/OPEQ/OIDRH/DMD/VIR1/
  301-796-6188
  stefanie.akselrod@fda.hhs.gov
 Marina V. Kondratovich
  FDA/OC/CDRH/OPEQ/OIDRH/
  301-796-6036
  marina.kondratovich@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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