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...
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...
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...
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...
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...
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...