Label Verification –FDA UDI (Unique Device ID) Mandate Challenge: • Adequately identify medical devices through manufacturing, distribution & use • Labels include UDI in human & machine-readable form • 1D/2D codes content & print quality inspection per GS1 & ISO specs Solution: • Microscan LVS Verifiers є Off-line (95xx line) with IQ/OQ for validated environments, 21 CFR Part 11 ready є In-Line (75xx) є USP: Off-/In-line consistency Phased implementation • (Sept, 2014 - 2020) • Class II DPM 2018 deadline • Long tail of smaller MDM companies still not compliant • Extensions and pushouts by the FDA in early 2017