This event focuses on two key areas in MedTech: the distinction between wellness and regulated health technologies, and the integration of artificial intelligence throughout the product lifecycle.

This article discusses the impact of US state laws banning food ingredients. It examines two recently enacted state laws that require a warning or disclosure statement on the label, but do not ...

SAN DIEGO @ After years of challenges and delays in implementing the Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR), a top industry expert said there is hope that the ...

The World Health Organization (WHO) issued an alert on Monday identifying oral cough syrups manufactured in India that contain diethylene glycol (DEG), a substance typically used as an industrial ...

PITTSBURGH @ US Food and Drug Administration (FDA) officials invited industry to discuss options for using a new approval pathway that broadens consumer access to nonprescription drugs and offered ...

Welcome to another installment of This Week at FDA, your weekly source for updates@big and small@on FDA, drug, and medical device regulation and what we@re reading from around the web. This week, ...

Medical device and pharmaceutical industry groups in the EU and US are urging significant changes to the EU@s Medical Device Regulation (MDR) and In Vitro Diagnostic Regulation (IVDR). Europe@s ...

The European Medicines Agency (EMA) has begun accepting the Food and Drug Administration@s (FDA) findings from inspections of facilities outside the US.

Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US The limits of FDA flexibility are tested as a controversial Biohaven drug decision nears (STAT) Trump ...

Global regulatory harmonization in the medical device sector is essential for ensuring timely patient access to safe and effective technologies while reducing redundant regulatory burdens. This ...

Over the past decade, the global landscape of medical device quality management has undergone a significant transformation. While ISO 13485:2016 provides a common foundation, regional adaptations ...

SAN DIEGO — Medtech companies should go beyond regulatory requirements when strengthening the cybersecurity of their medical devices to set them apart from their competitors, according to experts who ...