![]() Note that the accredited agency you select is a supplier that provides a service. To date, FDA has accredited three agencies: GS1, Health Industry Business Communications Council (HIBCC), and ICCBBA. These organizations are called accredited agencies or, because they issue the DI, issuing agencies. Instead, it comes from an organization accredited by FDA. The device manufacturer does not assign the device identifier (DI). However, many complexities add complications. ![]() Load the data into the FDA-CDRH Global Unique Device Identification Database (GUDID), and update the quality systems procedures. Ensure the format for any human‑readable dates are in the required format. Include the production identifiers (PI) that you have selected, and make sure they are both machine‑readable and human‑readable. Put the device identifier (DI) on the device label in machine‑readable form. On the surface, unique device identification (UDI) is a simple concept. By Dan O'Leary, President, Ombu Enterprises
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