Recognized Consensus Standards: Medical Devices

Part B: Supplementary Information Sheet (SIS)

FR Recognition List Number

020

Date of Entry 09/09/2008 

FR Recognition Number

13-23

Standard

CLSI  LIS08-A
Standard Guide for Functional Requirements of Clinical Laboratory Information Management Systems

Scope/Abstract

This guide covers the capabilities needed for a Clinical Laboratory Information Management System (CLIMS). It was written so that both vendors/developers of CLIMS and laboratory managers would have a common understanding of the requirements and logical structure of a laboratory data system. This guide will also provide more uniformity in the way that requirements are expressed from one laboratory to another.

Extent of Recognition

Complete standard

Public Law, CFR Citation(s) and Procode(s)*

Regulation Number	Device Name	Device Class	Product Code
§862.2100	Calculator/Data Processing Module, For Clinical Use	Class 1	JQP

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

Yan Zhang   CDRH/OPEQ/OHTVII/DMGP/MGB/   301-837-7386   yan.zhang1@fda.hhs.gov

Thomas Miller   CDRH/OPEQ/OHTVII/DCTD/CB/   240-402-8938   Thomas.Miller@fda.hhs.gov

Standards Development Organization

CLSI Clinical Laboratory Standards Institute https://clsi.org/

FDA Specialty Task Groups (STG)

Software/Informatics (primary)

InVitro Diagnostics

*These are provided as examples and others may be applicable.