FDA
The new article addresses the aspects related to the design considerations for diagnostic clinical performance studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
Malaysia
The new article describes in detail the aspects related to the roles and responsibilities of the entities engaged in operations with medical devices. Table of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of medical devices,...
Australia and Oceania
The new article provides additional details regarding the applicable regulatory requirements for the content and format of interim and final post-approval study reports. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
Brazil
The new article highlights the points related to the regulatory approach to be applied in the case of various products intended to collect and process electrocardiography data. Table of Contents The Brazilian regulating authority in the sphere of healthcare products...
Australia and Oceania
The new article highlights certain specific aspects related to clinical outcome studies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document...
