United States Medical Device Regulations

Nov 16, 2023

FDA Guidance on Electronic Submissions for 510(k): Current Template

The new article highlights the aspects related to the current version of the electronic submission template and outlines the key points to be considered by submitters (applicants).

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FDA Draft Guidance on Electronic Submissions for De Novo Requests: Overview

Nov 15, 2023

FDA

FDA Draft Guidance on Electronic Submissions for De Novo Requests: Overview

The article describes in detail the aspects related to the use applicability of the electronic submission framework in case of innovative products to be placed on the market.

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: MRI Safety Labeling

Nov 9, 2023

FDA

FDA Revised Guidance on MR Safety: MRI Safety Labeling

The new article describes in detail the aspects related to different types of MRI safety labelling to be used to indicate the safety status of the device intended to be marketed and used in the US.

RegDesk Regulatory Roundup

FDA Guidance on Electronic Submissions for 510(k): Current Template

FDA Revised Guidance on MR Safety: Overview

FDA Revised Guidance on MR Safety: Displacement Force and Torque

FDA Draft Guidance on Electronic Submissions for De Novo Requests: Overview

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

FDA Revised Guidance on MR Safety: MRI Safety Labeling

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