Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
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025
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Date of Entry 10/04/2010
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FR Recognition Number
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7-212
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Standard | |
CLSI EP18-A2 Risk Management Techniques to Identify and Control Laboratory Error Sources; Approved Guideline - Second Edition |
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Scope/AbstractThis 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. |
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Extent of Recognition
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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 |
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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. |
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FDA Technical Contacts
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Standards Development Organization
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FDA Specialty Task Group (STG)
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*These are provided as examples and others may be applicable. |