The FDA has issued new draft guidance on the Global Unique Device Identification Database (GUDID). This document was developed to revise “Section III. Policy On Standard Date Formatting, #UDI #Labeling, and GUDID Submission Requirements for Class I and Unclassified Devices” of the 2020 UDI Compliance Policy Guidance.
The draft guidance explains there are certain class I devices that are considered consumer health products for which FDA does not intend to enforce GUDID submission requirements under 21 CFR 830.300.
The draft guidance also describes how a labeler of a class I device can determine if their device is within the scope of this compliance policy.
