Hey, Gary Saner and Michelle Lott! Saurabh needs your help!

In addition to the prevailing medical device 510(k) process for FDA clearance, establishment registration, and product listing, you will need to comply with the FDA Unique Device Identification (UDI) regulations before commercially distributing you product. As reference, the full UDI is comprised of a required Device Identifier (DI) and a conditionally required Production Identifier (PI), i.e., UDI = DI + PI. The DI identifies the Labeler company and a particular product model/version. The PI includes Expiry Date, Mfg Date, Batch/Lot Number, Serial Number, or HCT/P DIN, if they appear on the device label.

UDI Label Regulations: The Full UDI must be presented in both 1) easily readable plain-text (Human Readable Interpretation, HRI) form and 2) Automatic Identification and Data Capture (AIDC) form, e.g., 1D or 2D barcode, on the device product and packaging labels per one of the FDA-approved Issuing Agencies (GS1 GTIN – most common, HIBCC, or ICCBBA). In addition, standalone Dates on device labels must be in YYYY-MM-DD format.

UDI Direct Marking Regulations: The Full UDI must be Directly Marked (DM) on devices that are multiple use (i.e., repeated uses on or by different patients) and are reprocessed (i.e., undergo high-level disinfection and/or sterilization before each use). The Full UDI must appear on the device in HRI, or AIDC, or both formats.

UDI Reporting to FDA: The UDI DI and device attributes (a total of 57 attributes) must be reported to the FDA GUDID repository. In addition, UDI data must be included in various reports and records.

Refer to the FDA UDI website at https://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/default.htm

Please contact me for UDI details, exceptions, and implementation steps. Thanks.
Gary Saner, gsaner@reedtech.com, http://www.ReedTech.com

Hi Saurabh. Get my Regulatory Pathway Analysis to help you navigate the 510k considerations. https://leanraqa.com/about/regulatory-pathways-assessment/

You can start the process for getting a GUDID but won’t be able to complete it until the 510k is cleared. Put some time on my calendar if you would like to discuss. https://letsmeet.io/michellelott/30-minute-consultation

Good luck!

Thanks, Joe, for providing a platform to connect with medical device experts.
Thanks to Gary Saner and Michelle Lott for sharing their thoughts on my question. Really appreciated you all for help.

Hi Saurabh,
The sequence of events is important to know as well:
1) prepare your 510(k)
2) submit your 510(k)
3) obtain DIs from GS1 or another agency
4) create your labeling process and validate
5) obtain 510(k) clearance
6) apply for GUIDID access
7) upload information to database
Currently the FDA has an option process for uploading a sample label with UDI codes as part of the registration process. However, this is a pilot and I expect this to be mandatory sometime in the future.
Rob Packard
https://medicaldeviceacademy.com
rob@13485cert.com

Hi Robert,
Thanks for your response.
It means I can submit my 510k without DIs ?
Actually I was thinking to have DI & PI before submitting the 510k. Please correct me if I am wrong.

Yes, that is correct. The DIs are not required in the draft labeling or anywhere else as part of the submission. You can include a placeholder to show where a barcode will be placed, but even that is not required. Currently you can optionally upload a sample label with the DI when you register and list–after 510(k) clearance. However, I expect that option to be mandatory sometime in the future.

Hi Robert
Thanks for clearing my doubt. 🙂