RegDesk Regulatory Roundup

Dec 28, 2023

BfArM Guidance on Fast-Track Process for Digital Health Applications: Life Cycle

The article highlights the aspects related to the life cycle of the digital health applications included in the respective directory.

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Introduction

Dec 20, 2023

FDA

FDA Guidance on Assessing the Credibility of Computational Modeling and Simulation: Introduction

The article provides a general overview of the guidance document issued by the US authority and highlights the key points related to the existing legal framework.

HSA Guidance on IVD Registration Submissions: Manufacturing Information

Oct 13, 2023

HSA

HSA Guidance on IVD Registration Submissions: Manufacturing Information

The new article highlights the aspects related to the information to be included in the submissions with respect to manufacturing processes and sites involved. Table of Contents The Health Sciences Authority (HSA), a Singapore’s regulatory agency in the sphere of...

FDA Guidance on Fostering Medical Device Development: Quality Domains and Performance Measures

Oct 4, 2023

FDA

FDA Guidance on Fostering Medical Device Development: Quality Domains and Performance Measures

The article addresses the aspects related to the approach medical device manufacturers should apply when assessing the actual performance of their products placed on the market in the context of the Voluntary Improvement Program. Table of Contents The Food and Drug...

HSA Guidance on IVD Registration Submissions: Device Labeling and Risk Analysis

Oct 3, 2023

HSA

HSA Guidance on IVD Registration Submissions: Device Labeling and Risk Analysis

The article addresses the aspects related to the labeling requirements in vitro diagnostic devices should comply with, as well as the approach to be applied with respect to risk analysis in order to ensure the proper health protection and safety of patients. ...

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