FDA
The new article highlights the critical points related to the regulatory framework for novel medical devices intended to be marketed and used in the US.
Canada
The new article provides a general overview of the essential information to be included in the medical device application to ensure its completeness.
Australia
The new article provides additional details regarding the subsequent steps of the recall process, including the development of an action strategy, drafting a communication strategy to be followed when conducting a recall, and also the matters related to interactions with the authority, such as the noes associated with the submission of the relevant notification and an assessment to be conducted by the TGA
FDA
The article provides an overview of the regulatory approach to be applied concerning certain regulatory matters.
Canada
The new article describes in detail the recall process, highlighting the most important aspects associated with it.
