FDA
The present article provides an overview of the guidance document dedicated to manufacturing information and operations in the context of premarket approval applications. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating...
FDA
The article provides additional details regarding the medical device patient labeling. In particular, it describes the requirements regarding the appearance of text and graphics. Table of Contents The Food and Drug Administration (FDA or the Agency), the US...
FDA
The article provides additional details regarding the aspects related to training and labeling to be reflected in an investigational plan. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
FDA
The article highlights specific aspects related to medical device patient labeling as described in the appendixes to the respective guidance document. In particular, the article explains the way the manufacturers may improve the readability of medical device patient...
FDA
The new article highlights the aspects related to the investigation plan and the way it should be developed. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulatory authority in the sphere of healthcare products, has published a...
FDA
The new article provides the details regarding the troubleshooting information to be included in medical device patient labeling. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products,...
