FDA
The article provides an overview of the applicable regulatory requirements for ethical considerations in the context of clinical investigations of medical devices initially intended to be used for children. Table of Contents The Food and Drug Administration (FDA or...
FDA
The new article highlights the key points related to the principles for the choice of clinical study design, such as bias and variability and the way they can affect the accuracy and reliability of the results. Table of Contents The Food and Drug Administration (FDA...
FDA
The new article describes in detail the aspects to be considered when identifying a medical device recall to distinguish it from other actions. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
FDA
The new article describes the types of medical devices covered by the scope of the guidance and highlights the key points to be taken into account in this respect. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
FDA
The new article describes in detail the main concepts used in the context of medical device recalls and enhancements in terms of determination of their legal nature and actions to be taken by the parties involved. Table of Contents The Food and Drug Administration...
FDA
The new article provides additional details regarding some of the matters related to evidence, including the benefit-risk assessment. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
