HSA
The new article describes in detail the approach to be followed when applying for registration and marketing approval for Class A and B medical devices.
FDA
The new article describes the matters related to periodic evaluations the authority intends to conduct to ensure compliance with the applicable regulatory regiments.
FDA
The new article highlights the aspects related to the content and format of an application for initial recognition and re-recognition as a third-party 510k review organisation.
EU
The new article describes in detail the applicable classification approach and highlights the key considerations associated thereto.
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.
