Patient safety Archives

Nov 15, 2023

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.

Nov 9, 2023

BfArM

BfArM Guidance on Fast-Track Process for Digital Health Applications: Evidence – Positive Care Effect

The new article describes the approach to be followed by the applicants when presenting sufficient evidence demonstrating the proper performance of their products when used for the intended purpose.

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.

EDA Guidance on Reporting Adverse Reactions: Responsibilities of Users

Nov 3, 2023

EDA

EDA Guidance on Reporting Adverse Reactions: Responsibilities of Users

The article highlights the key points related to the responsibilities of persons using healthcare products in the context of reporting adverse reactions thereto.

EDA Guidance on Reporting Adverse Reactions: Pharmacovigilance Basics

Nov 3, 2023

EDA

EDA Guidance on Reporting Adverse Reactions: Pharmacovigilance Basics

The document clarifies the aspects related to pharmacovigilance and its importance for ensuring continuous safety of medical devices allowed for marketing and use in the country.

RegDesk Regulatory Roundup

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

BfArM Guidance on Fast-Track Process for Digital Health Applications: Evidence – Positive Care Effect

FDA Revised Guidance on MR Safety: MRI Safety Labeling

EDA Guidance on Reporting Adverse Reactions: Responsibilities of Users

EDA Guidance on Reporting Adverse Reactions: Pharmacovigilance Basics

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