FDA’s unique device identification system is designed to adequately identify devices through distribution and use.Its requirements were designed to be phased in over seven years according to established compliance dates based primarily on device classification.
The compliance dates established for class I and unclassified devices, other than implantable, life-supporting, or life-sustaining (I/LS/LS) devices are:
· September 24, 2018, for the following requirements:
o Standard date formatting (21 CFR 801.18),
o Labeling (21 CFR 801.20, 21 CFR 801.50), and
o Global Unique Device Identification Database (GUDID) data submission (21 CFR 830.300); and
· September 24, 2020, for direct mark requirements (21 CFR 801.45).