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 ...
Team-NB has shared proposals for how to stop “lengthy debates” between manufacturers and notified bodies about the applicability of a rule about the need for clinical data on medical devices.
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 ...
The International Council for Harmonisation (ICH) has endorsed the eCTD @ the electronic common technical document @ as the message standard for electronic submissions. This article presents an ...
PITTSBURGH — Is it worth agreeing to an early orientation meeting with the US Food and Drug Administration (FDA) about your medical device software? Alex Cadotte, vice president of Digital Health, AI, ...
Medical device manufacturers are required to undertake a range of postmarket surveillance (PMS) activities to comply with regulatory requirements to ensure the safety and performance of their devices ...
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 ...
Welcome to Regulatory Reconnaissance, your regulatory news and intelligence briefing. In Focus: US Inside FDA, career staffers describe how political pressure is influencing their work (STAT) The long ...
Artificial intelligence (AI) is already writing code, generating requirements, and suggesting test cases — but how do RA/QA teams maintain oversight when these tools operate inside regulated workflows ...
The US Food and Drug Administration (FDA) will only conduct vital and mission critical activities amid a government shutdown that began Wednesday after Congress failed to reach a deal to fund the ...
@The US Food and Drug Administration@s (FDA) final guidance on software assurance in computer and data processing systems for medical device production includes more examples and a new section ...
The European Medicines Agency (EMA) and the Heads of Medicines Agencies (HMA) are running a survey to inform research priorities for the use of artificial intelligence in the development and ...
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