In collaboration with the In Silico World (ISW) and SIMCor consortia, the VPH Institute has provided feedback to FDA on the draft guidance for Assessing the Credibility of Computational Modeling and Simulation in Medical Device Submissions.
This draft guidance builds on the risk-based assessment framework of the ASME (V&V40) and develops further the concept of credibility evidences for computational models. A call for feedback to the public had been launched since December 2021. The feedback letter from the two consortia have been received and made public by FDA on the 28th of March 2022 (https://www.regulations.gov/docket/FDA-2021-D-0980/comments).
The full documents can be found here:
- Comments from In Silico World
Further information can be found here
