GUDID and UDI – Are You Prepared?
The Global Unique Device Identification Database (GUDID) is a database administered by the FDA that will serve as a reference catalog 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 labeler (e.g., manufacturer) within the healthcare supply chain.
Under the UDI rule, the labeler of each medical device labeled 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 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, machine-to-machine solution will help medical device suppliers achieve compliance with UDI requirements for America, ensure data validation and submission, enhance master data quality and reduce operational & IT costs.
It’s Time to Ask…
- Have you identified the scope of Class I 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 data to the FDA?
- Do you have a primary source of truth for product information?
- Can your product master data be ‘trusted’ by your customers and the regulators?
If you’ve answered ‘No’ to any of these questions, it’s time to establish a primary source of product information to ensure that master data you share with the FDA can be trusted and accurate.