FDA
The new article outlines the key points of the newly issued guidance document addressing the matters related to malfunction reporting. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
Brazil
The new article addresses the aspects related to the regulatory requirements to be applied with respect to the software products intended to be used for various purposes, including diagnosing and interaction with laboratory equipment. Table of Contents The Brazilian...
EU MDR/IVDR
The article provides an overview of the guidance document explaining how Article 97 MDR should be applied to legacy devices. Table of Contents The Medical Device Coordination Group (MDCG), an advisory body of the European Commission in the sphere of medical devices,...
FDA
The new article describes how clinical data should be handled and highlights the key points to be considered in this respect. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
FDA
The new article highlights the key points related to potential failure of a responsible party to comply with a requirement to conduct a post-approval study, and also to the situations when information about post-approval studies is being disclosed. Table of Contents...
