FDA
The new article describes in detail the approach to be applied with respect to data collection and reporting in the context of animal studies.
Australia
The article outlines the roles and responsibilities of the parties involved in recalls and related activities to be taken to ensure the safety and proper performance of medical devices and other healthcare products allowed for marketing and use in the country.
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.
