FDA
The new article highlights the aspects to be considered by medical device manufacturers in order to ensure the safety and proper performance of their products utilizing novel technologies. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
FDA
The new article highlights the aspects related to the main types of requests to be applied depending on the situation and review stage. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
Africa
The new article highlights the aspects related to the classification rules to be applied with respect to invasive medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA), a country’s agency responsible for ensuring the safety...
Africa
The new article highlights the aspects related to be taken into consideration with respect to the classification of active medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA), a country’s regulatory agency in the sphere...
FDA
The new article highlights the aspects related to the labeling for new assay-instrument combinations, and also to the way the information about them should be added to a public database. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
