FDA Approves First Contraceptive Mobile App

International – Considering icons for mobile applications and connected medical devices

It seems like there is a new smartphone, mobile app, or connected device on the market every month. These increasingly “smart” mobile applications, dashboards,...
Medical devices: the shift from embedded to connected

International – Survey shows solid medical device industry performance despite pandemic impact

Medical device and IVD manufacturers report healthy performance over the course of 2020, but also faced significant operational and regulatory challenges related to the...
IMDRF Seeks Input on Regulatory Pathways for Personalized Medical Devices

International – Update of IMDRF terminologies for categorized Adverse Event Reporting (AER)

Release Notes for IMDRF Terminology Edition 5.0 Edition 5.0 incorporates the Change Requests received for the 2020 maintenance cycle. Due to the late notification of...

International – IEC 60601-1 3rd Ed., 2nd Amendment An Overview

The application of IEC 60601-1 Edition 3:2005 including Amendment 1: 2012 (General requirements for basic safety and essential performance) resulted in a list of issues...
ISO 14971 :2019 - GAP-ANALYSIS résumé versus l’ancienne version ISO EN FR 14971 : 2013.

International – Norme ISO 14155:2020 : quels changements pour quels impacts ?

Révisée en juillet dernier mais toujours en attente d’harmonisation, la norme ISO 14155 traite des Bonnes Pratiques Cliniques à suivre tout au long d’une...
IMDRF Seeks Input on Regulatory Pathways for Personalized Medical Devices

International – L’IMDRF publie un document concernant la classification des DMDIV

The objective of the International Medical Device Regulators Forum (IMDRF) is to encourage convergence at the global level in the evolution of regulatory systems...

International – Facebook développe une montre connectée tournée vers la santé

Malgré son échec face à Google lors de la vente de Fitbit en 2019, Facebook est bien décidé à entrer sur le marché des...
Saudi FDA extends GHAD deadlines, issues guidance documents

Saudi Arabia – Saudi classification guidance explicates submissions process and product changes

The Saudi Food and Drug Administration (SFDA) has published version 4.1 of the Saudi FDA Products Classification Guidance. New in this version is a section...

International – January’s Regulatory Focus: The impact of disruption on the global regulatory community

Feature articles during January focused the effects of disruption on global regulatory practice. In context of the COVID-19 pandemic, authors examined expedited approval pathways...
WHO drafts guidance for pharma supply chain tracking

International – WHO’s Essential Diagnostics List updated for COVID-19

The World Health Organization (WHO) updated its list of essential diagnostics for 2021 on Friday to include recommendations for polymerase chain reaction and antigen-based...

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