An Introduction to GUDID #101
What is a GUDID?
The Global Unique Device Identification Database (GUDID) is a database created by the U.S. FDA to register all medical devices marketed and sold in the US market. It serves as a repository of key master data for device identification. This key information is limited to Device Identifiers and Labeler information.
Why was GUDID established?
The FDA established the unique device identification (UDI) system to adequately identify medical devices sold in the United States from manufacturing through distribution to patient use in order to improve patient safety, modernize post-market surveillance, and facilitate medical device innovation. The GUDID was established to serve as the repository for all this UDI information.
Where does it apply?
The GUDID is based in the United States, and this regulation applies to all medical devices sold in the US.
What is required?
Every “labeler” of medical devices is required to maintain UDI data and submit this information to the GUDID. Devices are grouped into three risk classifications (Class III, Class II, Class I) with differing submission deadlines. Note that for the equivalent European regulation, the responsibility for UDI submission lies with a manufacturer of the medical device.
Are there deadlines?
Suppliers of Class III and Class II devices have already had to meet submission deadlines of 2018 and 2016 respectively. Class I devices have an upcoming deadline of September 2020.
We keep hearing about “21 CFR Part 11” compliance. What is it?
Title 21 of the Code of Federal Regulations establishes the United States FDA’s regulation on electronic records and electronic signatures (ERES). Part 11 sets out how a company operating in the US can use electronic quality records and digital signatures in place of paper-based documentation and ‘wet signatures’ in such a way that complies with FDA regulations.
Who/What needs to comply with 21 CFR Part 11?
Compliance is essential for those FDA regulated companies that wish to use electronic quality records and electronic signatures to comply with FDA regulations faster and more efficiently (in lieu of their paper-based and ink-based counterparts).
Do you need more information?
There are lots of great resources available to help. Here are a few Innovit favorites.
HIBCC (Health Industry Bar Code UDI Standards)
GS1 UDI Resource Page