FDA
The new article highlights the aspects related to additional submission types that could be used in specific cases and also describes the approach to be applied when no relevant submission type is used. Table of Contents The Food and Drug Administration (FDA or the...
FDA
The article provides an overview of the questions and answers document issued by the US regulating authority and highlights the key points related to Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in healthcare...
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...
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...
FDA
The new article highlights the aspects related to the documenting requirements, as well as to the concept of an instrument family and the way it should be applied in the context of using an assay with an instrument from a different family. Table of Contents The Food...
