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...
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...
The article provides an overview of the existing regulatory requirements related to the abridged processing of applications for medical devices. Table of Contents The Food and Drug Administration (FDA) Philippines, a country’s regulatory agency in the sphere of...
The new article describes in detail the way the appropriate assurance activities 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 published a guidance...
The article provides an overview of the regulatory policy for low-risk medical devices. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document...