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Letter/Comment
AHRMM LUC Comments to the FDA’s Communications About the Safety of Medical Devices
The AHRMM LUC members submitted public comments and recommendations at the FDA's November 2020 meeting related to the need to include the UDI in the recall process. They highlighted the prototype recall database and electronic submission form, as well as survey data supporting its creation.
Learning UDI Community, Unique Device Identifier (UDI), Medical Device Safety, Supply chain management, Regulatory Compliance, Patient Safety Risk, Medical Device Regulation
I&L Committee Topic: Ethylene Oxide (EtO) Sterilization
AHRMM Issues & Legislative (I&L) Committee identifies, reviews and follows the regulatory, environmental, quality of service and standards matters that impact the health care supply chain field. Each I&L Committee member closely monitors an important topic and compiles an update with useful information to help AHRMM members stay ahead of policy issues that affect their work and health care organization.
Issues & Trends, Advocacy & Public Policy, Legislation and Legislative Advocacy, Risk Management, Supply chain management, Medical Device Regulation, Medical Device Safety
Letter/Comment
AHRMM Comment Letter to FDA RE: “Modernizing FDA’s Data Strategy”
In September 2019, FDA announced its Technology Modernization Action Plan (TMAP).  The TMAP describes important near-term actions that FDA is taking to modernize use of technology—computer hardware, software, data and analytics—to advance FDA’s public health mission. The TMAP will provide a foundation for developing a more fluid, agile, and efficient FDA that is scaled to respond to novel technologies and a rapidly increasing workload.
Learning UDI Community, Unique Device Identifier (UDI), Medical Device Safety, Supply chain management, Regulatory Compliance, Patient Safety Risk, Serious Adverse Events, Medical Device Regulation