FDA
The article highlights the key points related to the specific aspects to be considered when using real-world data to support marketing applications related to medical devices.
FDA
The new article addresses the aspects related to various matters associated with the licensing process for establishment licenses.
FDA
This article highlights the aspects related to the approach to be applied when determining whether a notification is required.
FDA
The article highlights the key points related to notification requirements medical device manufacturers should follow with respect to possible discontinuance or interruption in the manufacturing process.
FDA
The article describes in detail the approach to be applied for credibility factors and credibility goals to be considered by the parties responsible for medical devices.
FDA
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.
