FDA Draft Guidance on Evidentiary Expectations for 510(k) Implant Devices: Overview
The article highlights the key points associated with the concept of evidentiary expectations in the context of marketing submissions.
The article highlights the key points associated with the concept of evidentiary expectations in the context of marketing submissions.
A comprehensive overview of three essential aspects of computational modeling: code verification results, model calibration evidence, and bench test validation results.
Each of these plays a vital role in ensuring the accuracy and reliability of computational models in various scientific and engineering domains.
The article describes in detail the approach to be applied when assessing the credibility evidence responsible parties are expected to submit.
The article describes in detail the approach to be applied when assessing the credibility evidence responsible parties are expected to submit.
The article highlights the key points associated with the electronic submissions template described by the US authority.