FDA Partially Finalizes UDI Database Guidance, With More To Come-thegraysheet: FDA finalized guidance for companies making submissions to its global unique device identification database today – sort of. In an usual move, the agency decided to finalize specific sections of the guidance, while maintaining draft status for other parts. “To provide labelers with the most accurate information as soon as it is available, we are finalizing this document in two phases,” the agency writes in a notice announcing the new guidance (PDF). The first part of the finalized guidance, which is now available, addresses the issues that received the most comments and questions. The updated version of the guidance will officially be published on June 11.
