Australia and Oceania
The new article describes in detail the approach to be applied concerning comparable devices including substantially equivalent devices. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating authority in the sphere of healthcare...
Australia and Oceania
The present article provides a brief overview of the regulatory matters related to the clinical evaluation reports to be submitted by the parties responsible for clinical trials. Table of Contents The Therapeutic Goods Administration (TGA), an Australian regulating...
FDA
The new article addresses the aspects related to warnings and precautions 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, has...
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...
