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

January 19, 2018

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 &

801.50), GUDID Data

Submission (21 CFR 830.300), and Standard Date Format (21 CFR 801.18) requirements before:

FDA does not intend to enforce Direct Mark requirements (21 CFR

801.45) before:

     
Class 1 and unclassified devices manufactured and labeled on or after September 24, 2018 September 24, 2020 September 24, 2022
Finished class 1 and unclassified devices manufactured and labeled before September 24, 2018 September 24, 20218 September 24, 2022

See newly released FDA Guidance document

8 As explained above, and consistent with 21 CFR 801.30(a)(1), finished class I and unclassified devices manufactured and labeled before September 24, 2018, are excepted from the UDI labeling and GUDID submission requirements by regulation until September 24, 2021.