USA – This Week at FDA: User fee update, Califf nomination…

Welcome to another edition of This Week at FDA! There were some major developments this week with potential ramifications for FDA in the coming...
FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected medical devices and health care networks that use certain communication software

USA – FDA informs patients, providers and manufacturers about potential cybersecurity vulnerabilities for connected...

Today, the U.S. Food and Drug Administration is informing patients, health care professionals, IT staff in health care facilities and manufacturers of a set of cybersecurity...
ANVISA will implement new rules for medical device modifications in Brazil

Brazil – Brazil OKs COVID-19 test from Chembio Diagnostics

Chembio’s DPP SARS-CoV-2 antigen test has received regulatory clearance from Brazil’s health regulator ANVISA. The 20-minute test detects viral antigens specific to SARS-CoV-2 to determine...

USA – Cybersecurity in Medical Devices: Quality System Considerations and Content of Premarket Submissions

The need for effective cybersecurity to ensure medical device functionality and safety has become more important with the increasing use of wireless, Internet- and...
FDA finalizes guidance on clinical, in vitro drug interaction studies

USA – FDA Warns Against Using Implanted Pumps With Unapproved Drugs

The US Food and Drug Administration (FDA) on Wednesday warned physicians against using implantable pumps to deliver pain medications directly into patients’ spinal fluid...
Modernizing ClinicalTrials.gov: NIH Seeks Feedbackowser for precision medicine research

USA – Modernizing ClinicalTrials.gov: NIH Seeks Feedback

As part of a multi-year modernization initiative, the National Institutes of Health’s (NH) National Library of Medicine (NLM) is seeking comments from users and...
Medical devices are bigger culprit in antibiotic-resistant infections than surgical procedures: CDC analysis

USA – Medical devices are bigger culprit in antibiotic-resistant infections than surgical procedures: CDC...

Healthcare-associated infections (HAIs) that are antibiotic-resistant resulted more frequently from use of temporary medical devices than from surgical procedures, according to an analysis of...

USA – Final FDA guidances focus on improving device trials

The US Food and Drug Administration (FDA) issued two final guidance documents on Tuesday that aim to help sponsors better incorporate and capture patients’...
Integrated Device Design Critical to Rapid Medical IoT Development

USA – Integrated Device Design Critical to Rapid Medical IoT Development

Medical IoT holds the promise of vastly improved patient outcomes, along with the potential for an evolutionary step-change in the way healthcare is managed...

Canada – Foreign risk notification for medical devices guidance document

This guidance document is to help manufacturers and importers of medical devices understand and comply with the regulatory requirements on foreign risk notification (FRN)....

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