Recognized standard
SW91:2018
FDA recognition 13-105 · ANSI · Software/Informatics
Key facts
| Recognition number | 13-105 |
|---|---|
| Designation | SW91:2018 |
| Title | Classification of defects in health software |
| Standards developer | American National Standards Institute |
| Specialty area | Software/Informatics |
| Date of entry | Jan 14, 2019 |
| Scope (excerpt) | This standard provides a common language for the classification of defects occurring in health software. |
At a glance
- None 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: