| CLSI LIS03-A Standard Guide for Selection of a Clinical Laboratory Information Management System |
| Recognition Date | 2008-09-09 |
| Recognition List | 020 |
| Recognition Number | 13-18 |
| Extent | Complete standard |
| Standards Orgs | CLSI Clinical Laboratory Standards Institute https://clsi.org/ |
| STG | Software/Informatics |
| FDA Tech | James Mullally FDA/OMPT/CDRH/OIR/DCTD/CTXB/ 240-402-5021 james.mullally@fda.hhs.gov |
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This 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.
| Regulation Number | Device Name | Device Class | Product Code |
| §862.2100 | Calculator/Data Processing Module, For Clinical Use | Class 1 | JQP |
| There is no relevant guidance developed at this time. |