
FDA Guidance on De Novo Classification Process: Basics
The new article highlights the critical points related to the regulatory framework for novel medical devices intended to be marketed and used in the US.
The new article highlights the critical points related to the regulatory framework for novel medical devices intended to be marketed and used in the US.
The article provides an overview of the reclassification process commenced by the US medical device regulatory agency.
Also, it outlines the specifics of such a process in the context of high-risk in vitro diagnostic medical devices.
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...
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...
This article talks about the Unique Device Identification System for Medical Devices, its timelines and regulatory requirements across various countries. Table of Contents The use of medical devices is essential in healthcare, with millions of devices being used...