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...
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...
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...
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...
The article provides a brief overview of the approach to be applied for medical device recalls and enhancements, including the determination of their regulatory nature and the requirements to be followed. Table of Contents The Food and Drug Administration (FDA or the...