FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to medical device reporting. The document is intended to provide additional clarifications and...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare products, has published a guidance document dedicated to Unique Device Identifiers. Apart from other aspects, the guidance covers the matters related to...
FDA
The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of medical devices, has published a guidance document dedicated to the Brain-Computer Interface (BCI) medical devices. The document highlights the most important aspects...
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...
