Mandy is a green hand of US medical devices, so maybe the questions are a lot.
Today's question is about the De-Novo and Early Collaboration, due to the Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff, Early Collaboration Meetings (Agreement Meetings & Determination Meetings) are specific to the early stage of development like before IDE, and applicable to clinical investigations. So can a novel prodcut apply for De-Novo Program and conduct Early Collaboration Meetings?
Today's question is about the De-Novo and Early Collaboration, due to the Early Collaboration Meetings Under the FDA Modernization Act (FDAMA); Final Guidance for Industry and for CDRH Staff, Early Collaboration Meetings (Agreement Meetings & Determination Meetings) are specific to the early stage of development like before IDE, and applicable to clinical investigations. So can a novel prodcut apply for De-Novo Program and conduct Early Collaboration Meetings?
