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.
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