Even before the FDA’s final rule was published for UDI in 2013, companies were implementing UDI systems. What has not been clear is how the FDA would enforce UDI compliance. The most logical methods of enforcing UDI compliance are:
1. require a draft labeling to include sample UDI bar codes as part of all regulatory submissions, and
2. require that the device identifier (DI) be entered for each device during the registration and listing process for devices.

Class III devices and Class II implants already are required to have UDIs implemented, but all Class II devices must be compliant by September 24, 2016. However, the final rule does not specifically explain whether labelers must obtain UDIs prior to regulatory clearance of new Class II products.

Therefore, there are three possible outcomes if a 510(k) is not submitted draft labeling including a UDI for each Class II device:
1. an RTA hold letter is issued during the first 15 days of the review process,
2. the submission is placed on hold and the reviewer sends the applicant a request for additional information that includes draft labeling with a UDI, or
3. a 510(k) clearance letter is received, but the company is unable to register and list the device without entering a DI for each product.

The FDA’s refusal to accept (RTA) checklist does not currently include a requirement for UDI labeling, but there is a requirement to submit draft labeling and the FDA requests UDI labeling to be submitted with a 510(k) premarket notification. I have not yet seen an RTA issued due to the lack of a UDI, but that could be a potential policy change in the future.

The second scenario is far more likely, but for devices that were cleared prior to the implementation deadline for the product classification I have not observed any delays. This is likely to become a frequent outcome for devices that have been submitted this month, because the submissions will be undergoing the substantive review process when the implementation deadline of September 24 passes.

Currently the registration and listing process does not require entry of a DI for each product, but the registration and listing database has a new pilot feature that allows companies to upload labeling with UDIs voluntarily to the database. This pilot allows the FDA to debug the uploading process so the FDA can ensure the uploading process will function properly when and if UDIs are mandatory for the registration and listing process.

Therefore, if you are submitting a new 510(k) for a Class II device now, you will need to engage an accredited issuing agency and request DIs for the subject device(s) before you submit your 510(k).

There are only three organizations that are accredited for issuing UDIs:
1. GS1 – http://www.gs1.org
2. HIBCC – http://www.hibcc.org
3. ICCBBA – http://www.iccbba.org

GS1 is the largest issuer of UDIs globally and ICCBBA specializes in UDIs for tissue banking.

In addition to obtaining a DI for each device from one of the issuing agencies, you also must submit the information to the Global UDI database (GUDID):

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/ucm20038750.htm

If you have additional UDI questions, the FDA instructs all manufacturers that they can only submit questions to the FDA UDI help desk:

http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/ucm368904.htm

There is also a free webinar available for download from my website:

http://medicaldeviceacademy.com/fda-udi-regulations-impact-medical-device-labelers/

I will be sending out UDI information updates to people that have completed the form and confirmed that they want to receive updates.

source: https://www.linkedin.com/groups/2070960/2070960-6176005381593001988