FDA
The new article addresses aspects related to submission issue requests as a specific type of submission under the Q-Submission program. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority in the sphere of healthcare...
Africa
The new article describes in detail the approach to be applied with respect to in vitro diagnostic medical devices, provides an overview of the classification principles, and highlights the key points to be considered in this respect. Table of Contents The South...
FDA
The new article highlights the aspects related to the updated procedures to be reflected in a Modification Protocol as a part of marketing submission for medical devices utilizing machine learning technology. Table of Contents The Food and Drug Administration (FDA or...
FDA
The new article highlights the aspects related to the general approach to the changes related to software products and also describes the most important concepts used. Table of Contents The Food and Drug Administration (FDA or the Agency), the US regulating authority...
Uncategorized
Periodic Safety Update Reports (PSURs) are critical documents for medical device and in vitro diagnostic product manufacturers. These reports are a key component of a manufacturer’s post-market surveillance and risk management program, providing ongoing...
Africa
The document highlights the key points related to the current classification rules for different types of medical devices. Table of Contents The South African Health Products Regulatory Authority (SAHPRA), the country’s national regulator agency, has published a...
RegDesk is recognized as a Regulatory Intelligence Representative Vendor! Learn more by reading the 2024 Gartner® Market Guide for Regulatory Intelligence Solutions.
Get the report
