FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Special Considerations
The new article addresses the aspects related to various matters associated with the licensing process for establishment licenses.
The new article addresses the aspects related to various matters associated with the licensing process for establishment licenses.
This article highlights the aspects related to the approach to be applied when determining whether a notification is required.
The new article highlights the aspects related to specific categories of credibility evidence the authority will expect medical device manufacturers to collect to demonstrate compliance with the relevant regulatory requirements, as well as the safety and proper performance of their products in general.
The article describes in detail the approach to be applied when assessing the credibility evidence responsible parties are expected to submit.
The new article highlights the aspects related to the general regulatory framework for computational modelling and simulations used in the healthcare sphere in the context of medical device development.