Recognized standard
TIR45:2023
FDA recognition 13-143 · AAMI · Software/Informatics
Key facts
| Recognition number | 13-143 |
|---|---|
| Designation | TIR45:2023 |
| Title | Guidance on the use of AGILE practices in the development of medical device software |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | Software/Informatics |
| Date of entry | May 26, 2025 |
| Device classes | Class 2 |
| Scope (excerpt) | Over the past several years, AGILE software development has become an accepted method for developing software products. There have been questions from both manufacturers and regulators as to whether (or which) AGILE practices are appropriate for developing medical device software. Enough medical… |
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: