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The FDA plans to unveil by Oct. 1 its own quality metrics for devicemakers based on three metrics from a pilot program conducted by Xavier Health and the Medical Device Innovation Consortium. Read More
The FDA is attempting to harmonize performance standards with International Electrotechnical Commission standards for certain X-ray imaging devices. Read More
The FDA announced it does not intend to enforce the requirement to use its unique device identifier system for labels on medical devices manufactured and labeled before Sept. 24, 2021. Read More