FDA
The new article highlights the aspects related to the applicable policy and outlines the key points to be taken into consideration. Table of Contents The Food and Drug Administration (FDA), the US regulating authority in the sphere of healthcare products, has...
FDA
The new article highlights the aspects related to the general approach to the changes related to software products and also describes the most important concepts used. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
FDA
The article highlights the key points related to monitoring clinical investigations as prescribed by the applicable legislation. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products,...
FDA
The new article describes in detail the aspects related to the applicability of recommendations provided in the guidance in terms of medical devices and regulatory pathways. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
FDA
The article outlines the key points associated with the changes to software-based medical devices marketed in the US. Table of Contents The Food and Drug Administration (FDA or the Agency) has published a draft guidance document dedicated to a predetermined change...
