FDA
The article highlights the aspects related to existing submission formats and key considerations associated thereto in the context of the Voluntary Improvement Program. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
FDA
The new article addresses the aspects related to the voluntary improvement program introduced by the US regulating authority. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
FDA
The article provides a general overview of the guidance document dedicated to the approach the US regulating authority intends to apply in order to facilitate medical device improvement while ensuring compliance with the applicable regulatory requirements. Table of...
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...
