FDA
The present article provides an overview of the applicable regulatory policy introduced by the authority. 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...
FDA
The new article addresses the aspects related to the connection between different sections of a predetermined change control plan, as well as to the impact assessment medical device manufacturers should perform in order to ensure the modifications will not affect the...
FDA
The new article highlights the aspects related to the updated procedures to be reflected in a Modification Protocol as a part of marketing submission for medical devices utilizing machine learning technology. Table of Contents The Food and Drug Administration (FDA or...
FDA
The article describes in detail the regulatory approach to be applied with respect to contact lenses allowed for marketing and use in the US. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
FDA
The new article highlights the aspects related to specific tests to be conducted by medical device manufacturers in order to demonstrate compliance with the applicable regulatory requirements. Table of Contents The Food and Drug Administration (FDA or the Agency), the...
FDA
The new article addresses the aspects related to the Modification Protocol section, especially to its content in general and data management practices in particular. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in...
