Recognized standard
AUTO11-A2
FDA recognition 7-344 · CLSI · InVitro Diagnostics
Key facts
| Recognition number | 7-344 |
|---|---|
| Designation | AUTO11-A2 |
| Title | Information Technology Security of In Vitro Diagnostic Instruments and Software Systems; Approved Standard - Second Edition |
| Standards developer | Clinical Laboratory Standards Institute |
| Specialty area | InVitro Diagnostics |
| Date of entry | May 26, 2025 |
| Device classes | Class 1 |
| Scope (excerpt) | This document provides a framework for communication of information technology security issues between the in vitro diagnostic system vendor and the health care organization. |
At a glance
- 1–9 Product codes
- 1–9 FDA guidance documents
Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.
About FDA-recognized consensus standards
The FDA recognizes voluntary consensus standards that manufacturers can cite in premarket submissions to show conformity with specific requirements.
Source: U.S. Food and Drug Administration (FDA), Recognized Consensus Standards database · Source date: