medical device regulation Archives

Nov 16, 2023

BfArM Guidance on Fast-Track Process for Digital Health Applications: Data Security

The new article addresses the aspects related to the data security measures to be introduced by the parties involved in operations with digital health products.

FDA Guidance on Selecting Predicates for 510(k): Introduction

Nov 15, 2023

FDA

FDA Guidance on Selecting Predicates for 510(k): Introduction

The article describes the basics of the approach the applicants should follow when selecting a predicate device to demonstrate substantial equivalence.

FDA Revised Guidance on MR Safety: Hazards Explained

Nov 3, 2023

FDA

FDA Revised Guidance on MR Safety: Hazards Explained

The article highlights the aspects related to various hazards associated with the use of medical devices magnetic resonance environment.

FDA Guidance on Non-Invasive Remote Monitoring Devices: Overview

Nov 1, 2023

FDA

FDA Guidance on Non-Invasive Remote Monitoring Devices: Overview

The article provides an overview of the revised guidance document issued by the US authority to address certain regulatory matters and ensure legal clarity.