What is the significance of UDI date requirements for Class 1 devices?

[SGquality]

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!

 

[SGquality]

Can some one help me on this please. Thank you!

 

[Schkund]

Looking at the referenced CFR section 801.45, it appears that the Direct Mark requirement is for any device that is intended to be reused with some sort of reprocessing between uses... these sorts of devices must have a permanent mark directly on the device along with the UDI on the packaging.



801.45 Devices that must be directly marked with a unique device identifier.

(a)In general. A device that must bear a unique device identifier (UDI) on its label must also bear a permanent marking providing the UDI on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use.



With regards to the FDA's timeline, it looks like you're referring to Figure 1 on the FDA page titled "Compliance Dates for UDI Requirements"

After comparing the table with the letter that is linked underneath it, it looks like the FDA has extended the deadline to implement UDI labelling on Class I medical devices from 24 September 2018 to 24 September 2020 (as long as it is not a life-saving device). That's my interpretation, but it would be nice to hear it from an authority on the matter!

 

[ASteel]

I read it as any device manufactured on or after Sept 24, 2018, they would not enforce UDI until Sept 24, 2020 (as long as it is not life-saving or require direct marking); however, you would still need to have the data submitted to GUDID by Sept 24, 2018.

Does this mean that labeling on product made in between Sept 24, 2018 and Sept 24, 2020 (if at mfg facility) will need reworked before distribution?

 

[Ronen E]

Does this mean that labeling on product made in between Sept 24, 2018 and Sept 24, 2020 (if at mfg facility) will need reworked before distribution?

If it's not compliant with UDI requirements, yes.
The only USA UDI requirement that is still not mandatory (not for long though) is the one relating to direct marking of single-use reprocessable class I devices.