FDA
The new article describes in detail the approach to be applied concerning documenting the review process, its completion, and reporting.
FDA
The new article highlights the aspects related to the review process itself.
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.
