FDA issues final guidance on devices containing animal-derived materials

USA – FDA issues final guidance on devices containing animal-derived materials

FDA has issued final guidance on medical devices containing animal or animal-derived materials. The guidance supersedes the version issued in 1998 and expands...
FDA’s OCP Works to Modernize Review Functions

USA – FDA’s OCP Works to Modernize Review Functions

Modernized regulatory review functions for drugs and biologics applications were implemented at the US Food and Drug Administration’s (FDA) Office of Clinical Pharmacology (OCP)...
New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

UK – New Batch of MHRA No-Deal Brexit Guidance for Drugs, Devices

With a little more than a week left before the UK could depart from the EU without a deal, the UK’s Medicines and Healthcare...
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...
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...
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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