FDA
The new article highlights the key points related to comparison to existing medical devices, as well as the labeling used. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
COVID-19
The new article highlights the key points related to regulatory requirements for modifications to medical devices allowed for marketing and use. Table Of Contents: The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
COVID-19
The article provides an overview of the existing regulatory framework and highlights the key points to be considered. Table of Contents Regulatory Background The present guidance covers the matters related to the 510(k) submissions for photobiomodulation (PBM)...
Saudi Arabia
The new article addresses the aspects related to device-specific requirements, and also describes the procedures to be followed when applying for marketing approval. Table Of Contents: The Saudi Food & Drug Authority (SFDA), a country’s regulatory agency in the...
FDA
The new article highlights the aspects related to reprocessing of photobiomodulation devices. 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Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a draft guidance...
Asia
The new article highlights the aspects related to changes to existing licenses and also addresses some other matters, such as the registration rules applicable to specific types of medical devices. Table Of Contents The National Health Regulatory Authority (NHRA),...
