FDA
The article provides a brief overview of the existing regulatory requirements for computer software assurance in the context of medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
FDA
The present article describes in detail the way the least burdensome approach should be applied. In particular, it explains the ideas behind the concept of the minimum information necessary. Table of Contents The Food and Drug Administration (FDA or the Agency), the...
FDA
The article provides an overview of the regulatory requirements for monkeypox tests intended to address the public health emergency. In particular, the document describes the current situation with the virus and outlines special extraordinary measures FDA is going to...
FDA
The new article describes in detail the responsibilities of the regulating authority concerning the determination of risk associated with medical device studies; and also provides some examples illustrating the way the approach described in the guidance should be...
FDA
The new article highlights the aspects related to the main principles on which the least burdensome approach is based, and also describes the key points related to the said principles. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
FDA
The new article describes the responsibilities of institutional review boards (IRBs) when assessing clinical studies related to medical devices, as well as the approach to be applied when determining the regulatory status of such studies based on the risks associated...
