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.
Canada
The new article highlights certain specific matters to be addressed in all the applications for a medical device license in order to ensure the authority is provided with all the information needed to assess the safety and effectiveness of the product subject to review.
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
Australia
The new article describes in detail the applicable types and classes of recalls and also explains the difference between recalls and non-recall actions from a regulatory standpoint.
