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Under the agreement, Philips has agreed to continue service until Dec 31, 2022, and it will meet with the TGA twice yearly and report adverse events as required under normal operations. Read More
The software update patches the device’s external USB drive performance and its impact on GUI functionality and labeling displayed on the interface during device use. Read More
All site change supplements should clearly identify any changes to manufacturing locations and associated changes to the manufacturing process that result.
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For reclassification proceedings based on new information and proceedings calling for PMAs for a pre-FDASIA class II device, the agency must convene a classification panel and obtain panel recommendations.
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AdvaMed CEO Scott Whitaker called the tax “bad health policy and bad economic policy,” and praised the committee for including the 5-year extension of the moratorium. Read More
Examples of SaMD include software that makes a diagnosis using patient information, X-ray image processing software and smart phone apps that calculate a patient’s required insulin doses using their blood glucose levels. Read More