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.
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Jan 19, 2021
Jul 24, 2020
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.
Mar 19, 2019
Read this report on the recommended practices related to the allocation of multiple unique device indicators (UDI-DI) and suggested ways to mitigate the occurrence or negative implication of multiple UDI-DIs. Download Report