AAMI Backs Expanded Use of Consensus Standards Under MDUFA VI
The association says FDA’s proposed approach could strengthen the role of consensus standards in medical device regulation, maintenance, and international harmonization.
Tag: standards
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AAMI Signs Collaboration Agreement with Saudi Food and Drug Authority
The organizations will work together to develop best practices for medical device safety and emerging technologies, including artificial intelligence and biotechnology.
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FDA Recognizes Updated AAMI Sterilization Guidance
The FDA has added one new and three revised AAMI sterilization documents, including guidance on ethylene oxide, to its list of Recognized Consensus Standards.
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AAMI Backs Expanded Use of Consensus Standards Under MDUFA VI
The association says FDA’s proposed approach could strengthen the role of consensus standards in medical device regulation, maintenance, and international harmonization.
AdvaMed Lauds AI Task Force’s Call for Device Payment Pathway
AdvaMed applauds the House AI Task Force for calling on CMS to create payment pathways for AI-enabled devices.
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Kodiak Solutions Report Lists AI and Cybersecurity as Top Risks
Kodiak Solutions’ annual Top Risks list finds AI, cybersecurity threats, and regulatory compliance as key issues for health systems in 2025.
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ECRI Expands Total Systems Safety and HFE Solutions
ECRI has expanded its Total Systems Safety (TSS) and Human Factors Engineering (HFE) solutions to address preventable harm in healthcare.
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The Joint Commission and NAHQ Form Strategic Alliance
The Joint Commission and the National Association for Healthcare Quality have formed an alliance to advance global healthcare quality, focusing on quality competencies, professional certifications, co-developed training, and global best practices.
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FDA Updates Guidance on Third-Party 510(k) Review Program
The FDA issued updated guidance on the 510(k) Third Party Review Program and EUA Review, clarifying expectations, processes, and criteria.
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AAMI, Consumer Technology Association to Focus on AI Standards
AAMI and the Consumer Technology Association have signed an MOU to collaborate on creating industry standards for AI and machine learning in healthcare.
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ECRI Expands Operations in Canada
ECRI has expanded its operations in Canada, establishing its licensed presence and growing its team of healthcare experts.
