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...
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...
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...
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...
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,...