Recognized standard
CR515:2025
FDA recognition 13-153 · AAMI · Software/Informatics
Key facts
| Recognition number | 13-153 |
|---|---|
| Designation | CR515:2025 |
| Title | Cybersecurity Consideration Unique to Machine-Learning Enabled Medical Devices |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | Software/Informatics |
| Date of entry | Dec 22, 2025 |
| Scope (excerpt) | This consensus report specifically addresses the unique cybersecurity threats associated with developing and deploying machine learning-enabled medical device software, as distinct from the broader cybersecurity risks applicable to all medical device life cycle phases. This includes potential… |
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: