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U.S. Department of Health and Human Services

Recognized Consensus Standards: Medical Devices

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Part B: Supplementary Information Sheet (SIS)
FR Recognition List Number 041 Date of Entry 04/04/2016 
FR Recognition Number 7-259
CLSI  GP23-A2 (Replaces GP23-A)
Nongynecological Cytology Specimens: Preexamination, Examination, and Postexamination Processes; Approved Guideline - Second Edition
This document provides recommendations for cytology laboratories to use in developing preexamination, examination, and postexamination processes and procedures for nongynecological cytology specimen management.
Extent of Recognition
Partial recognition. The following part(s) of the standard is (are) not recognized:
Partial Recognition - The following part(s) of the standard is (are) not recognized:
Section 2.7.2 Digital Pathology
Section 2.7.3 Telepathology
Rationale for Recognition
This standard is relevant to medical devices and is recognized on its scientific and technical merit and/or because it supports existing regulatory policies.

This standard is recognized in part because:
Section 2.7.2 is in conflict with an existing regulation. See regulation below.
Section 2.7.3 is in conflict with an existing published final guidance. See Description and Test Methods for Each Component in sections IV(A), IV(B) and IV(C) of the guidance document cited below.
Public Law, CFR Citation(s) and Procode(s)*
Regulation Number Device Name Device Class Product Code
§864.1850 Stain, Ponceau Class 1 HZO
§864.3010 Slides, Microscope Class 1 KEW
§864.3300 Cytocentrifuge Class 1 IFB
§864.3600 Light, Microscope Class 1 IBJ
§864.3800 Stainer, Tissue, Automated Class 1 KEY
Relevant FDA Guidance and/or Supportive Publications*
21 CFR 864.3700 Whole Slide Imaging System.

Technical Performance Assessment of Digital Pathology Whole Slide Imaging Devices; Guidance for Industry and Food and Drug Administration Staff, Issued on April 20, 2016.

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 Contact
 Shyam Kalavar
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.