FDA issued a guidance establishing enforcement discretion that applies to FDA established compliance dates for certain class I and unclassified devices as set out below:
Class 1 and unclassified devices manufactured and labeled on or after September 24, 2018
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 24 September 2020
FDA does not intend to enforce Direct Mark requirements (21 CFR 801.45) before September 24, 2022
Could anyone tell me what is the difference between these two dates? and what is Direct Mark requirements?
Thanks!
Class 1 and unclassified devices manufactured and labeled on or after September 24, 2018
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 24 September 2020
FDA does not intend to enforce Direct Mark requirements (21 CFR 801.45) before September 24, 2022
Could anyone tell me what is the difference between these two dates? and what is Direct Mark requirements?
Thanks!