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.
Australia
The article highlights the key points related to the regulatory status of boundary products in Australia.
EU
The new article highlights the aspects related to the timelines associated with the clinical investigations, the way they should be calculated, and other relevant matters.
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.
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