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...
IMDRF
The new article highlights the aspects related to the first two stages of the total product life cycle, namely the initial development, when the product is being created, and support – the period that starts from the moment the product becomes available on 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...
Africa
The new article addresses the aspects related to the existing classification rules for non-invasive medical devices and the way they should be applied based on the device, its intended use, and other factors. Table of Contents The South African Health Products...
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...
Europe
The new article highlights the aspects related to the review of the application by the authority and regulatory decisions the authority may take based on the results of such a review. Table of Contents The Swiss regulatory agency in the sphere of healthcare products,...
