FDA Promises Flexibility for Stem Cell Trials

USA – CDRH to Review Materials Used in Medical Devices

Following recent high-profile safety issues related to materials used in implantable and insertable medical devices, US Food and Drug Administration (FDA) Commissioner Scott Gottlieb...
FDA Wants to Take a Hard Look at Medical Device Materials

USA – FDA Wants to Take a Hard Look at Medical Device Materials

As part of its effort to modernize its regulatory programs, FDA has turned its attention to materials used in medical devices.  The agency released a statement Friday from...
Australian medical device regulators preparing Brexit contingency plans

Australia – Australian medical device regulators preparing Brexit contingency plans

The Australian TGA has drawn up plans to blunt the impact of Brexit on the country’s medical device market. TGA will continue recognizing...
Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)

Europe – Increased requirements for clinical evidence under the new Medical Devices Regulation (MDR)

European MDR clinical data requirements may result in up-classification or recertification of some medical devices. Manufacturers with CE Marked devices should be preparing...
CDRH Tweaks Guidance on Medical Devices Containing Animal-Derived Materials

USA – CDRH Tweaks Guidance on Medical Devices Containing Animal-Derived Materials

The US Food and Drug Administration (FDA) on Thursday finalized guidance from 2014, with new details on medical devices containing animal-derived materials. The final guidance...
Health Canada Begins Release of Clinical Data on Drugs and Devices

Canada – Health Canada Begins Release of Clinical Data on Drugs and Devices

Health Canada launched two public databases on Wednesday as the first step in making clinical information about the safety and effectiveness of drugs and...
CDRH Classifies Respiratory Infection IVD, System for Neurological and Psychiatric Disorders

USA – CDRH Classifies Respiratory Infection IVD, System for Neurological and Psychiatric Disorders

The in vitro diagnostic (IVD) device for antibiotic susceptibility testing in respiratory samples and the transcranial magnetic stimulation system for neurological and psychiatric disorders were classified...
CDRH Qualifies 3rd Medical Device Development Tool

USA – CDRH Qualifies 3rd Medical Device Development Tool

A software module intended to aid health care providers in marking and classifying brain contusions became the third medical device development tool (MDDT) to...
ANSM - Prolapsus pelviens et de l’incontinence urinaire : Point d’étape sur les actions de contrôle et surveillance en cours

France – ANSM – Prolapsus pelviens et de l’incontinence urinaire : Point d’étape sur...

La réunion de concertation du 22 janvier 2019 a permis l’élaboration de pistes d’actions portées par les différentes autorités sanitaires afin de garantir la...
Top 10 Patient Safety Concerns in 2019

USA – Top 10 Patient Safety Concerns in 2019

Released in conjunction with National Patient Safety Awareness week, ECRI Institute's Top 10 Patient Safety Concerns for 2019 raises the profile of safety issues that pose...

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