FDA
The article provides an overview of key points and principles related to the least burdensome provisions. 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...
FDA
The article provides a brief overview of the regulatory requirements related to various studies medical devices could be subject to. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
FDA
The new article describes in detail certain additional aspects to be considered by medical device manufacturers applying for marketing approval concerning the manufacturing information to be included in such applications. Table of Contents The Food and Drug...
FDA
The new article describes in detail the aspects related to pretesting in the context of 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 the details regarding the review process and the key points to be considered in this respect. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of...
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...
