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AHA Letter to FDA on AI-enabled Medical Devices

The AHA supports AI policy frameworks that balance flexibility to drive market-based innovations with appropriate safeguards to protect privacy and patient safety.
Artificial Intelligence (AI), Medical Device Regulation

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

AHRMM Comment Letter to FDA RE: “Modernizing FDA’s Data Strategy”

In September 2019, FDA announced its Technology Modernization Actio
Learning UDI Community, Unique Device Identifier (UDI), Medical Device Safety, Supply chain management, Regulatory Compliance, Patient Safety Risk, Serious Adverse Events, Medical Device Regulation