USA – Biocompatibility Testing of Medical Devices – Standards Specific Information for the Accreditation...
This guidance provides information on how the Biological Evaluation of Medical Devices standards are incorporated into the Pilot Accreditation Scheme for Conformity Assessment Program...
Europe – Ongoing consultations under the PECP
This page lists the views provided by the in vitro diagnostics expert panel under the Performance Evaluation Consultation Procedure (PECP) according to Article 48(6)...
Europe – Factsheet for authorities in non-EU/EEA states on medical devices and in vitro...
In April 2017, the European Parliament and the Council adopted the Medical Devices Regulation (EU) 2017/745 (MDR) and the In Vitro Diagnostic Medical Devices...
International – IMDRF guidance updates thinking on personalized medical devices
The International Medical Device Regulators Forum (IMDRF) says personalized medical devices (PMD) come in three varieties that require different regulatory approaches. As certain technologies...
USA – FDA weight-loss device guidances address clinical and non-clinical studies
A decade in the making, the US Food and Drug Administration (FDA) has published two complementary draft guidances for sponsors developing weight-loss devices. The...
USA – FDA’s final breakthrough devices guidance now includes technologies that address health disparities
Final guidance on the US Food and Drug Administration breakthrough device program includes new language noting that the program now can be used to...
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...
