COVID-19
The new article addresses the matters related to modifications to photobiomodulation devices, provides definitions of the most important terms and concepts used, and also describes warnings and precautions to be included in labeling. Table of Contents The Food and...
Asia
The new article addresses the matters related to the applicable review timelines, fees payable, and changes to registered combination products. Table Of Contents The Medical Device Authority (MDA), a Malaysian regulatory agency in the sphere of medical devices, has...
FDA
The article provides an overview of the official guidelines dedicated to classification rules and requirements for medical devices intended to be marketed and used in the US. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating...
Saudi Arabia
The new article highlights the aspects related to managing the risks associated with medical devices based on novel technologies. Table of Contents The Saudi Food & Drug Authority (SFDA), a country’s regulatory agency in the field of healthcare products, has...
COVID-19
The new article describes in detail the aspects related to clinical trials, including the determination of study endpoints and duration, as well as follow-up schedule, statistical considerations, and adverse events monitoring. Table of Contents The Food and Drug...
COVID-19
The new article covers the general matters related to clinical investigations with photobiomodulation devices involved. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
