{"id":5633,"date":"2016-04-24T15:19:47","date_gmt":"2016-04-24T13:19:47","guid":{"rendered":"http:\/\/www.thema-med.com\/come-implementare-efficacemente-il-programma-unique-device-indentification-udi-fda\/"},"modified":"2023-01-24T14:59:53","modified_gmt":"2023-01-24T13:59:53","slug":"how-to-effectively-implement-the-unified-device-identification-udi-fda-program","status":"publish","type":"post","link":"https:\/\/www.thema-med.com\/en\/2016\/04\/24\/how-to-effectively-implement-the-unified-device-identification-udi-fda-program\/","title":{"rendered":"How to effectively implement the Unified Device Identification (UDI) FDA program"},"content":{"rendered":"

The UDI application required by the FDA may be considered an easy and fast task, which simply requires affixing a barcode on the device. But this is not the case.<\/p>\n

This operation does not end in two minutes and must be properly considered by the company that intends to keep on marketing in the USA in the near future.<\/p>\n

The UDI program can indeed be considered as one of the most significant regulatory changes introduced in the last few years by the FDA (perhaps you are also interested in “USA: wake up … FDA is talking!<\/strong><\/a>“) and it should not be underestimated. Here we will try to explain why, in the knowledge that this is a difficult and complex topic that cannot be described in a nutshell.<\/p>\n

The UDI program is not only affixing a barcode but it requires further more complex compliance such as including data into the GUDID database, an FDA-designed tool for tracking and tracing all devices placed on the US territory and how the impact on the quality system is challenging for Italian companies that are already failing to comply with 21 CFR requirements.<\/p>\n

This important change should be considered as a real internal project and even managed with a specific preventive action, in order to address all aspects of the activities to be carried out and involve all relevant business functions.<\/p>\n

The first aspect to consider in all activities to be implemented is planning, a term not so in line with the Mediterranean personality, but essential to do things properly and in time.<\/p>\n

The FDA provides deadlines to market devices complying with the Program, depending on the device type and class (including software with some exceptions):<\/p>\n