RegDesk Regulatory Roundup

Dec 11, 2024

DRAP Guidelines on National Pharmacovigilance System: Safety Communication and Risk Minimization

The new article provides additional clarifications regarding the approaches to be followed when communicating important safety-related information and also outlines special risk minimization measures to be taken by the parties involved.

FDA Draft Guidance on Section 524B: Documentation

Apr 8, 2024

FDA

FDA Draft Guidance on Section 524B: Documentation

The new article further elaborates on the scope of documentation to be provided concerning cybersecurity devices intended to be marketed and used in the US.

FDA Draft Guidance on Section 524B: Specific Aspects

Apr 8, 2024

FDA

FDA Draft Guidance on Section 524B: Specific Aspects

The new article provides additional details regarding specific aspects associated with cyber devices, such as modifications to it.

FDA Revised Guidance on MR Safety: Image Artifact and Reporting Results

Nov 16, 2023

FDA

FDA Revised Guidance on MR Safety: Image Artifact and Reporting Results

The article addresses the aspects related to possible image artifacts and the way they should be treated and also describes the approach to be applied when reporting results.

ISO 14971 Risk Management for Medical Devices

Oct 11, 2023

ISO Standards

ISO 14971 Risk Management for Medical Devices

This article highlights details of ISO 14971 and its significance in ensuring the safety and quality of medical devices. Table of Contents In the field of medical device development and manufacturing, ensuring the safety and effectiveness of products is of paramount...