Recognized standard
TIR38:2019
FDA recognition 6-422 · AAMI · General Plastic Surgery/General Hospital
Key facts
| Recognition number | 6-422 |
|---|---|
| Designation | TIR38:2019 |
| Title | Medical device safety assurance case guidance |
| Standards developer | Association for the Advancement of Medical Instrumentation |
| Specialty area | General Plastic Surgery/General Hospital |
| Date of entry | Jul 15, 2019 |
| Device classes | Class 2, Class 3 |
| Scope (excerpt) | This TIR is a safety case development reference for medical device design. The TIR is intended to provide a framework within which experience, insight, and judgment are applied systematically to assure and document the safety of a medical device's design. |
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: