A Few Things SaMD Developers Should Know

USA – A Few Things SaMD Developers Should Know

In today’s digital and connected society, clinicians and patients alike are beginning to expect the same capabilities in medicine. There’s tremendous opportunity for healthcare...
Biosimilars Forum Calls for FDA Guidance to Address Misinformation

USA – CDRH Issues Final Orders on Medical Devices for Insulin Adjustment, Drug Screening

The Center for Devices and Radiological Health (CDRH) at the US Food and Drug Administration (FDA) issued two final orders on Wednesday, classifying the...
FDA, USP Clash Over Biologics Monographs

USA – Spring Regulatory Agenda for FDA: What New Rulemakings are Coming

The US Food and Drug Administration (FDA) on Wednesday published its plans for the latest proposed and final rulemakings for drug and medical device...
Spain Introduces Portal for Electronic Reporting of Medical Device Adverse Events

Spain – Spain Introduces Portal for Electronic Reporting of Medical Device Adverse Events

The Spanish Agency of Medicines and Medical Devices (AEMPS) has introduced an electronic portal to facilitate the reporting of incidents involving medical devices. AEMPS’...
With new blood test, Roche dives deeper into personal cancer care

International – With new blood test, Roche dives deeper into personal cancer care

The blood test, called FoundationOne Liquid, is among initial products to emerge from Foundation Medicine after Roche spent $2.4 billion on the U.S.-based genetic...
FDA Expands RWE Demonstration Project

USA – US FDA Launches Pilot to Expand Special 510(k) Market Pathway

EMERGO SUMMARY OF KEY POINTS: US FDA launching pilot program to expand Special 510(k) route for modifications to medical devices. Pilot would allow more...
AdvaMed Raises Concerns Over FDA’s Medical Device Safety Action Plan

Dispositifs Médicaux – AdvaMed Raises Concerns Over FDA’s Medical Device Safety Action Plan

In a comment submitted on the US Food and Drug Administration’s (FDA) recent action plan to promote medical device safety, the Advanced Medical Technology...
FDA Proposes Regulatory Framework for AI- and Machine Learning-Driven SaMD

USA – FDA Proposes Regulatory Framework for AI- and Machine Learning-Driven SaMD

The US Food and Drug Administration (FDA) requested feedback Tuesday on a new discussion paper that proposes applying a “focused review” approach to premarket...
Italian medical device nomenclature to be adapted for Eudamed database

Italy – Italian medical device nomenclature to be adapted for Eudamed database

The European Medical Device Coordination Group (MDCG) plans to use Italy’s CND codes as the basis for the Eudamed device database nomenclature. CND...
Draft Brexit Agreement’s Implications for Medical Device Sector

Europe – Draft Brexit Agreement’s Implications for Medical Device Sector

A draft agreement on Brexit has been struck between EU and UK negotiators. Notified Bodies will remain recognized during the transition period. It...

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