FDA Adds AAMI Sterilization Guidance to Standards Database
FDA has recognized four AAMI sterilization documents in its Consensus Standards Database, including updated guidance on ethylene oxide usage.
Category: Regulations & Standards
Regulations & Standards
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Regulations & Standards
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AAMI Updates Ethylene Oxide Sterilization Standard
AAMI has updated its ethylene oxide (EO) sterilization standard, ANSI/AAMI ST24:2024, addressing new technologies and industry challenges.
Regulations & Standards
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Joint Commission, National Quality Forum Joins Forces
The Joint Commission and National Quality Forum (NQF) announced a strategic affiliation to accelerate improvements in health for all people.
Regulations & Standards
Latest
FDA Adds AAMI Sterilization Guidance to Standards Database
FDA has recognized four AAMI sterilization documents in its Consensus Standards Database, including updated guidance on ethylene oxide usage.
FDA Hiring More Experts to Help Healthcare ‘Unleash the Power of Data’
Commissioner Hahn says the FDA is hiring the best people to analyze healthcare data to make better decisions and adapt as technology changes.
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CDRH Director Says Flexibility Key as COVID-19 Strains Regulatory System
Jeffrey Shuren says the regulatory structure for medical devices needs to change and adapt with lessons learned from the COVID-19 pandemic.
Read MoreWSO2 Launches Open Healthcare Solution
WSO2 Healthcare Solution provides a complete platform for fast-tracking API-driven compliance and digital business innovation.
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AAMI Releases Complete Collection of Modern Dialysis Standards
AAMI is releasing Complete Dialysis Collection: 2020 edition, a comprehensive collection of 14 dialysis standards. New editions of the book will be regularly released to keep pace with the rapidly changing dialysis landscape.
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What Are the Biggest Technology Challenges Facing Healthcare?
An MD and chief medical officer discusses the technology challenges of making information quickly available to doctors while maintaining HIPAA compliance.
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FDA Explains How EUA Medical Devices Can Electronically Comply with AE Reporting Requirements
The FDA has outlined the steps facilities using EUA medical devices should take to comply with AE reporting requirements electronically.
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Regulations & Standards
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Optikos Receives ISO 13485:2016 Medical Device Certification
This ISO certification indicates that the Optikos Quality Management System meets the most current regulatory requirements for the design, manufacture, and distribution of medical devices.
