Mar 23, 2023
FDA
The new article provides additional clarifications regarding the aspects related to specific cases when assembly reports are required or not required Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
Read More
Mar 23, 2023
FDA
The new article highlights the aspects related to the concept of commercial availability, problematic assembly situations, and temporary installations (for instance, in case one of the existing components needs to be repaired). Table of Contents The Food and Drug...
Read More
Mar 23, 2023
FDA
The new article addresses the aspects related to the accessories and components of diagnostic x-ray equipment, including the approach to be applied with respect to compatibility matters. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
Read More
Mar 22, 2023
FDA
The new article describes the aspects related to the use of electronic form in certain aspects associated with clinical trials. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products,...
Read More
Mar 22, 2023
Saudi Arabia
The new article describes in detail the regulatory approach the authority intends to apply with respect to x-ray equipment in terms of assembly in order to ensure the safety and proper operations of the devices. Table of Contents The Food and Drug Administration (FDA...
Read More