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.
FDA
The new article describes in detail the approach the authority applies when reviewing De Novo requests about medical devices utilising novel technologies.
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
HSA
The article provides a general overview of the approach to be followed when preparing a submission associated with a medical device intended to be placed on the market in Singapore.
HSA
The new article clarifies the scope of information to be included in the submission to ensure all the essential matters are adequately addressed, the submission is complete, and the authority has all the necessary information to make the regulatory decision.
