Europe
The Medicines and Medical Devices Act 2021 (the Act), adopted on February 11, 2021, constitutes one of the basic elements of the UK`s legislation in the sphere of medical devices. The document outlines the rights and responsibilities of a Commissioner of Patient...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has issued a guidance document dedicated to the procedures for handling post-approval studies imposed by premarket approval application orders. The...
North America
The US medical device regulating authority, the FDA, terminated the Alternative Summary Reporting Program, used for reporting for over 10 years. Medical device manufacturers exempted from reporting were informed that they would also be required to submit reports....
North America
The medical device regulating authority in the United States, the FDA, issued special warning on cybersecurity threats related to cardiac implantable devices (ICDs). According to the document placed on the official website, the FDA aims to alert both companies and...
