FDA
The new article provides further clarifications regarding the clinical follow-up and supervision to be conducted by the parties responsible for clinical investigations.
Australia
The article highlights the key points associated with notifications for certain types of medical devices in the context of their specific regulatory nature.
FDA
The new article describes in detail a specific approach to be applied when developing a follow-up plan.
FDA
The final article of the cycle provides additional clarifications regarding certain specific aspects associated with the use of electronic records in the context of clinical investigations.
FDA
The new article highlights special considerations for IT service providers, as well as the ones related to the use of digital health technologies.
FDA
The new article emphasizes specific focus areas the authority will pay attention to when evaluating compliance in the context of electronic record-keeping procedures.
