United States
The new article highlights the aspects related to how the regulatory context should be considered when assessing real-world evidence and real-world data.
FDA
The new article highlights the aspects related to the device description to be included in premarket notification submissions under the respective legal framework.
CDRH
This article highlights the details of the adverse event reporting regulations in the European Union (EU) and the United States (US), their similarities, differences, and their impact on medical device safety. Table of Contents Ensuring the safety and effectiveness of...
CDRH
This article highlights the critical differences between FDA registration, clearance, approval, and granting for medical devices, offering essential insights for manufacturers and healthcare professionals navigating the regulatory landscape Table of Contents In the...
