USA – FDA updates medical device biocompatibility guidance with exclusion list
The US Food and Drug Administration (FDA) has updated its guidance on biocompatibility issues medical device sponsors should consider in their premarket submissions. This...
USA – Use of International Standard ISO 10993-1, « Biological evaluation of medical devices –...
FDA has developed this guidance document to assist industry in preparing Premarket Applications (PMAs), Humanitarian Device Exceptions (HDEs), Investigational Device Applications (IDEs), Premarket Notifications...
France – Déodorant Nuud : retrait du marché par le fabricant de l’ensemble des...
Des utilisateurs de ce déodorant ont fait état d’effets indésirables tels que des kystes douloureux au niveau des aisselles, parfois accompagnés d’une infection traitée...
USA – Recommendations for the Use of Clinical Data in Premarket Notification [510(k)] Submissions
As part of FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public
Health (herein referred to as the “Safety Action Plan”),1 FDA committed to...
USA – Evidentiary Expectations for 510(k) Implant Devices
As part of FDA’s Medical Device Safety Action Plan: Protecting Patients, Promoting Public
Health (herein referred to as the “Safety Action Plan”), FDA committed to...
USA – Best Practices for Selecting a Predicate Device to Support a Premarket Notification...
FDA developed this document to provide guidance to industry and FDA staff about best practices in selecting a predicate device for premarket notification ...
Australia – Medical devices vigilance program pilot
The TGA is commencing a new Medical Devices Vigilance Program (MDVP). The MDVP will begin as a 12-month pilot. The pilot is designed to...
USA – FDA finalizes guidance on use of human factors studies in combination product...
The US Food and Drug Administration (FDA) finalized its guidance for industry on the use of human factors engineering (HFE) studies to support the...
USA – FDA updates off-the-shelf software guidance to reflect least burdensome approach
The US Food and Drug Administration (FDA) has reissued a final guidance on off-the-shelf (OTS) software used by medical devices, which aims to reduce...
USA – FDA details proposed 510(k) modernization with trio of draft guidances
The US Food and Drug Administration (FDA) has announced new steps it is taking to modernize the 510(k) program, which include updates on its...
