RegDesk Regulatory Roundup -- Medical Device and Pharma

Nov 15, 2023

BfArM

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

The new article addresses the matters related to interoperability for medical software products.

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.

EDA Guidance on Reporting Adverse Reactions: MD Vigilance System

Nov 15, 2023

EDA

EDA Guidance on Reporting Adverse Reactions: MD Vigilance System

The new article highlights the aspects related to the vigilance system introduced to ensure the continued safety of medical devices allowed to be marketed and used in the country.

FDA Draft Guidance on Electronic Submissions for De Novo Requests: Overview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FDA Draft Guidance on Electronic Submissions for De Novo Requests: Overview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

HSA Draft Guidance on Clinical Evaluation: Overview

Nov 15, 2023

HSA

HSA Draft Guidance on Clinical Evaluation: Overview

The article provides a brief overview of the regulatory requirements in the sphere of clinical evaluation of healthcare 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.

RegDesk Regulatory Roundup

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

FDA Revised Guidance on MR Safety: Displacement Force and Torque

EDA Guidance on Reporting Adverse Reactions: MD Vigilance System

FDA Draft Guidance on Electronic Submissions for De Novo Requests: Overview

HSA Draft Guidance on Clinical Evaluation: Overview

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

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