The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalogue for every medical device with an identifier. Unique Device Identification (UDI) is a system to mark and identify medical devices (via bar codes) by the labeller (e.g., manufacturer) within the healthcare supply chain.
Under the UDI rule, the labeller of each medical device labelled with a unique device identifier (UDI) must submit information concerning that device to the GUDID, unless subject to an exception or alternative. Class I manufacturers are currently facing a September 2020 deadline.
GUDID & UDI – Are You Prepared?
The goal of GUDID & UDI is to help improve patient safety. For the manufacturers, UDI will improve internal processes, bolster master data quality, and provide more accurate reporting and visibility related to product recalls and counterfeit devices. Unfortunately, manual submission methods via data entry or Excel spreadsheet uploads are time consuming and error-prone. An automated solution will help organizations achieve compliance with local UDI requirements, ensure data validation and submission, enhance data quality and reduce operational and IT costs.
It’s Time to Ask…
Have you identified the scope of Class II products impacted?
Is your data sourced from multiple locations?
Is your data accurate and complete?
Do you have a formal data governance strategy?
Do you have a sustainable process to provide accurate product information to the FDA?
Do you have a primary source of product information truth?
If you’ve answered ‘No’ to any of these questions, it’s time to establish a primary source of product information to ensure the information you share with the FDA is trusted and accurate.
Learn UDI implementation strategies and identify a sustainable process to successfully publish product content to the GUDID with Innovit. Our UDI Compliance and Product Information Management (PIM) solutions solve these challenges by allowing device manufacturers to implement a “global system and unified process” that is fully integrated with internal systems to submit product data for multiple UDI recipients simultaneously.