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Monthly Archives: January 2018

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APS Regulatory Update: FDA Delays UDI Enforcement for Class I and Unclassified Devices

Category : FDA, Regulatory

US FDA has pushed back enforcement of unique device identification (UDI) compliance deadlines for some low-risk (Class I and Unclassified) medical devices by at least two years.  Table 1 below provides the compliance dates. Table 1: Compliance Dates for Class I and Unclassified Devices   Type of Device FDA does not intend to enforce UDI labeling (21 CFR 801.20 &

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