Brazil
The new article describes in detail the aspects related to the products intended to process medical records, as well as the ones based on the use of non-medical hardware platforms (smartphones). Table of Contents The Brazilian regulating authority in the sphere of...
FDA
The new article highlights the key points related to study population and planning, selection of study participants (subjects), and specimen collection. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere...
Asia
The new article covers the aspects related to the device-specific advertising requirements, as well as to the corrective measures to be taken with respect to non-compliances identified. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory...
FDA
The new article addresses the aspects related to the evaluation of post-approval study reports. 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...
Canada
The article provides an overview of the regulatory requirement related to clinical evidence for medical devices. Table of Contents Health Canada, the country’s regulating authority in the sphere of healthcare products, has published a guidance document dedicated to...
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...
