FDA have updated the consensus standards- as at 26/05/2025.
For the degree of recognition click on the recognition information column – Recognized Consensus Standards: Medical Devices
This includes many CLSI updates for IVDs including some software aspects. Below are just the IVD updates.
| 05/26/2025 | InVitro Diagnostics | 7-328 | Partial | CLSI | M100 35th Edition | Performance Standards for Antimicrobial Susceptibility Testing | |
| 05/26/2025 | InVitro Diagnostics | 7-329 | Complete | CLSI | EP06-EG 2nd Edition | Developer Validation of Linearity Establishment Guide | |
| 05/26/2025 | InVitro Diagnostics | 7-330 | Partial | CLSI | M38M51S 3rd Edition | Performance Standards for Antifungal Susceptibility Testing of Filamentous Fungi | |
| 05/26/2025 | InVitro Diagnostics | 7-331 | Complete | CLSI | AUTO02-A2 | Laboratory Automation: Bar Codes for Specimen Container Identification – Second Edition | |
| 05/26/2025 | InVitro Diagnostics | 7-332 | Complete | CLSI | AUTO01-A | Laboratory Automation: Specimen Container/Specimen Carrier; Approved Standard | |
| 05/26/2025 | InVitro Diagnostics | 7-333 | Complete | CLSI | AUTO04-A | Laboratory Automation: Systems Operational Requirements Characteristics and Information Elements; Approved Standard | |
| 05/26/2025 | InVitro Diagnostics | 7-334 | Complete | CLSI | AUTO05-A | Laboratory Automation: Electromechanical Interfaces; Approved Standard | |
| 05/26/2025 | InVitro Diagnostics | 7-335 | Complete | CLSI | POCT01-A2 | Point-of-Care Connectivity – Second Edition | |
| 05/26/2025 | InVitro Diagnostics | 7-336 | Complete | CLSI | LIS02-A2 | Standard Specification for Transferring Information Between Clinical Instruments and Computer Systems; Approved Standard-Second Edition. | |
| 05/26/2025 | InVitro Diagnostics | 7-337 | Complete | CLSI | AUTO08-A | Managing and Validating Laboratory Information Systems; Approved Guideline | |
| 05/26/2025 | InVitro Diagnostics | 7-338 | Complete | CLSI | AUTO10-A | Autoverification of Clinical Laboratory Test Results; Approved Guideline | |
| 05/26/2025 | InVitro Diagnostics | 7-339 | Complete | CLSI | AUTO09-A | Remote Access to Clinical Laboratory Diagnostic Devices via the Internet; Approved Standard | |
| 05/26/2025 | InVitro Diagnostics | 7-340 | Complete | CLSI | LIS01-A2 | Standard Specification for Low-Level Protocol to Transfer Messages Between Clinical Laboratory Instruments and Computer Systems – Second Edition. | |
| 05/26/2025 | InVitro Diagnostics | 7-341 | Complete | CLSI | AUTO03-A2 | Laboratory Automation: Communications with Automated Clinical Laboratory Systems Instruments Devices and Information Systems; Approved Standard – Second Edition | |
| 05/26/2025 | InVitro Diagnostics | 7-342 | Complete | CLSI | AUTO12-A | Specimen Labels: Content and Location Fonts and Label Orientation; Approved Standard | |
| 05/26/2025 | InVitro Diagnostics | 7-343 | Complete | CLSI | AUTO07-A | Laboratory Automation: Data Content for Specimen Identification; Approved Standard | |
| 05/26/2025 | InVitro Diagnostics | 7-344 | Complete | CLSI | AUTO11-A2 | Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard – Second Edition. | |
| 05/26/2025 | InVitro Diagnostics | 7-345 | Complete | CLSI | AUTO13-A2 (Formerly GP19-A2) | Laboratory Instruments and Data Management Systems: Design of Software User Interfaces and End-User Software Systems Validation Operation and Monitoring; Approved Guideline – Second Edition |
