FDA
The article describes the approach to be followed when submitting information related to sterilizing medical devices intended to be marketed and used in the US.
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 addresses the aspects related to the authority’s expectations associated with the respective program.
Australia
The article highlights the key points related to the regulatory status of boundary products in Australia.
