FDA
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...
FDA
The new article describes in detail the regulatory requirements to be applied concerning pivotal clinical investigations in terms of clinical evidence for domestic and foreign clinical studies. Table of Contents The Food and Drug Administration (FDA or the Agency),...
FDA
The article provides an overview of the regulatory policy related to the Abbreviated 510(k) Program and highlights the key points associated thereto. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
FDA
The article provides an overview of the regulatory policy for pivotal clinical investigations in terms of design considerations. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products,...
FDA
The new article describes in detail the aspects related to establishing the appropriate record for the assurance of the software used in the course of manufacturing activities. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
FDA
The new article highlights the aspects related to the way the risk related to general wellness products should be determined. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has...
