FDA
The article highlights the aspects related to the rights and responsibilities of Institutional Review Boards in the context of informed consent. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere...
Asia
The article addresses the aspects related to elements of the submission template associated with the device description and information about the product to be provided by the applicant for the authority to be able to conduct a review. Table of Contents The...
BfArM
The new article provides a general overview of the key points related to the inclusion of digital health products in the respective register. Table of Contents The German regulating authority, the Federal institute for Drugs and Medical Devices (BfArM) in the sphere...
FDA
The article provides a general overview of the guidance document dedicated to the approach the US regulating authority intends to apply in order to facilitate medical device improvement while ensuring compliance with the applicable regulatory requirements. Table of...
FDA
The article addresses the aspects related to the responsibilities of the parties involved in clinical investigations, namely, study sponsors and clinical investigators. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
Australia
The new article highlights the aspects related to Class IIb spinal implantable medical devices and also highlights some other points related to the recent changes to the applicable classification rules impacting the regulatory status of spinal implantable medical...
