Overview:

The United States Food and Drug Administration delays the enforcement of Unique Device Identification (UDI) for Class I (low risk) medical devices by 2 years from the date of compliance and will come in action from 24 September 2022.

FDA’s UDI guidance

As per the latest publication of the UDI guidance, Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use as per 21 CFR 801.45.

According to the final guidance, FDA does not expect manufacturers to make UDI labeling, date formatting and Global Unique Device Identification Database (GUDID) changes for Class I and unclassified medical devices until 24 September 2022. These setbacks were made in order to address the challenges for manufactures for medium and high-risk devices which is more demanding than low risk devices.

About Global Regulatory Partners

Global Regulatory Partners Inc, (GRP) is an American company that provides regulatory affairs, clinical, quality and safety services to medical devices and pharmaceutical companies globally. GRP headquarters is located in Massachusetts USA and its main affiliates are located in China, Japan, Brazil, Mexico and Argentina. GRP helps many life science companies register their products in different countries in compliance with local regulations.  To learn more, please contact us at  info@globalregulatorypartners.com

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