FDA Looks to Improve UDI Data Quality With Relaxed Limits on Labelers’ Corrections

USA – FDA Floats Regulating Hyaluronic Acid Products as Drugs, Not Devices

The US Food and Drug Administration (FDA) intends to consider reclassifying hyaluronic acid (HA) intra-articular products intended for treatment of knee osteoarthritis as a...
FDA Updates 1989 Policies on Diagnostic X-Rays as Electronic Products

USA – FDA Updates 1989 Policies on Diagnostic X-Rays as Electronic Products

Regulatory policies set forth in 1989 for manufacturers of diagnostic x-ray equipment were substantially updated via new US Food and Drug Administration (FDA) draft...
FDA updates endpoint guidance for cancer trials

USA – FDA Finalizes Rule to Simplify Medical Device Classification Procedures

The US Food and Drug Administration (FDA) issued a final rule Thursday to simplify its procedures for classifying and reclassifying medical devices. FDA said the...
FDA Finalizes Guidance on Changes to Device Manufacturing Sites

USA – FDA Finalizes Guidance on Changes to Device Manufacturing Sites

The US Food and Drug Administration (FDA) issued final guidance intended to help industry determine applicable requirements for a change to a medical device...
FDA clears mobile medical app to help those with opioid use disorder stay in recovery programs

USA – FDA clears mobile medical app to help those with opioid use disorder...

Today, the U.S. Food and Drug Administration cleared a mobile medical application (app) to help increase retention (the amount of time a patient participates)...
Bipartisan Bill would allow Drug Imports from Canada

Canada – Canada’s MDSAP Transition Deadline Fast Approaching

EMERGO BY UL SUMMARY OF KEY POINTS: Health Canada’s December 31, 2018 deadline for MDSAP transition imminent. Medical Device License (MDL) holders for Class...
FDA to Test PreCert De Novo Requests Under Pilot

USA – FDA Drafts Guidance on Oncology Companion Diagnostics

Developers of companion diagnostics were encouraged on Thursday to help guide the direction of newly drafted policies in support of broader labeling for a...
Benefits of ERP in an FDA-Regulated Environment

USA – Benefits of ERP in an FDA-Regulated Environment

This guide will examine how medical device manufacturers are increasingly turning to ERP systems to mitigate compliance risk and turn developmental concepts into commercialize...
FDA Looks to Improve UDI Data Quality With Relaxed Limits on Labelers’ Corrections

USA – FDA Proposes Rule to Implement New De Novo Classification Process

The US Food and Drug Administration (FDA) issued a proposed rule on Tuesday to establish requirements on the de novo review pathway for classifying...
Health Canada Details Medical Device Action Plan

Canada – Health Canada to Release Action Plan for Medical Devices Amid Reports of...

Following a first-of-its-kind investigation into serious patient injuries associated with use of implants, the Canadian Minster of Health called on Health Canada to issue...

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