Recognized Consensus Standards: Medical Devices

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)*

Regulation Number	Device Name	Device Class	Product Code
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/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.