RegDesk Regulatory Roundup

Nov 16, 2023

FDA Guidance on Electronic Submissions for 510(k): Overview

The article highlights the key points associated with the electronic submissions template described by the US authority.

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.

Sep 29, 2023

Canada

Health Canada Guidance on Determining Medical Device Application Type: Non-IVD Group, Group Family, System

The article highlights the aspects related to the regulatory status of such categories as “medical device group”, “medical device group family” and “medical device system”. Table of Contents Health Canada, the Canadian regulating authority in the sphere of healthcare...