Part B: Supplementary Information Sheet (SIS) |
FR Recognition List Number
|
020
|
Date of Entry 09/09/2008
|
FR Recognition Number
|
13-18
|
Standard | |
CLSI LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System |
|
Scope/AbstractThis guide covers the selection, purchase, use, enhancement, and updating of computer technology supplied by a vendor as a complete system in the clinical laboratory. The purpose of the guide is to assist hospitals, clinics, and independent laboratories through the entire automation project in order to minimize the risks and maximize the benefits. It also includes checklists of items and design aids to be considered at each stage of planning to assist in carrying out the project. |
|
Extent of Recognition
|
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
|
Standards Development Organization
|
FDA Specialty Task Groups (STG)
Software/Informatics (primary) |
InVitro Diagnostics |
|
*These are provided as examples and others may be applicable. |