Recognized standard
V&V 40-2018
FDA recognition 5-122 · ASME · General I (QS/RM)
Key facts
| Recognition number | 5-122 |
|---|---|
| Designation | V&V 40-2018 |
| Title | Assessing Credibility of Computational Modeling Through Verification and Validation: Application to Medical Devices |
| Standards developer | American Society of Mechanical Engineers |
| Specialty area | General I (QS/RM) |
| Date of entry | Jan 14, 2019 |
| Scope (excerpt) | This Standard provides a framework for assessing the relevance and adequacy of completed V&V activities that establish credibility of a computational model. The credibility should be commensurate with the degree to which the computational model is relied on as evidence of device performance… |
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: