FDA guidance Archives

Nov 16, 2023

FDA Guidance on Premarket Notifications for MRDD: Clinical Images and Device Modifications

The article highlights the aspects related to clinical images to be submitted by the applicant and also describes the approach to be applied concerning modifications to medical devices covered by the scope of the guidance.

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.

FDA Revised Guidance on MR Safety: Overview

Nov 16, 2023

FDA

FDA Revised Guidance on MR Safety: Overview

The article provides an overview of the regulatory requirements related to safety in the magnetic resonance environment and highlights the key points to be taken into consideration by medical device manufacturers and other parties involved.

FDA Revised Guidance on MR Safety: Displacement Force and Torque

Nov 15, 2023

FDA

FDA Revised Guidance on MR Safety: Displacement Force and Torque

The article highlights the aspects related to certain specific hazards associated with the use of medical devices in the magnetic resonance environment – namely, displacement force and torque.

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.

RegDesk Regulatory Roundup

FDA Guidance on Premarket Notifications for MRDD: Clinical Images and Device Modifications

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

FDA Revised Guidance on MR Safety: Overview

FDA Revised Guidance on MR Safety: Displacement Force and Torque

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

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