I recently had a medical device company contact me for help establishing a labeling process at their facility. During the conversation I asked them what they were doing to prepare for the GUDID deadline on 24 September 2016, to which they responded “Let’s tackle labeling first.”
The UDI regulation can be split into two major parts – Labeling and GUDID Submission. That comment got me thinking about how many companies are addressing just one side of the FDA’s UDI regulation rather than both at the same time.
Labeling requirements include 1) dates on labels to be formatted as YYYY-MM-DD and 2) the addition of a UDI compliant barcode (also called a UDI Carrier) using Automatic Identification & Data Capture (AIDC) and Human Readable Interpretation (HRI), if applicable. It may not seem like a lot of work to make these two changes, but have you considered:
- The number of templates that need to be updated
- Your document change control process for approving and releasing the labels
- The validation process for templates and label content
- Barcode verification to ensure compliance to the Issuing Agency standards
- Revising of quality management system documentation
GUDID Submission, the second major part of the regulation, requires submission of product data to the FDA’s Global Unique Device Identification Database (GUDID) by 24 September 20xx, the year depending on the risk classification of the device. 24 September 2016 is the deadline for ALL Class II devices. Product data, consisting of 62 attributes per DEVICE, must be collected and prepared according to the GUDID business rules for the data. These rules and the required data attributes can be found at http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/GlobalUDIDatabaseGUDID/UCM396595.pdf
After collecting the data, which could already be in one centralized location, or, as is more likely the case, spread out within an organization’s various electronic and paper systems, the organization must decide how to submit the data.
For companies with fewer part numbers (and by fewer, I would suggest no more than 100 if you want to maintain your sanity & eyesight) there is the manual method using the GUDID Web Interface https://gudid.fda.gov/gudid/. Expect to spend 20-30 minutes per DI record entering all 62 data fields (do the math here… 100 items x 62 data attributes/item = 6,200 data entry points…). If you have collected, validated and formatted your data properly, this is all the data entry time you will need. However, if there are any problems with the data like keying error or improper formatting, you will receive a very undescriptive error message that will require additional time and sanity to decipher it before crossing your fingers, tossing salt over your shoulder, knocking on wood and resubmitting the data.
The questionably “easier” submission method involves compiling the data into an HL7 SPL xml file and electronically submitting the data – one DI record at a time. But that is after setting up the FDA Electronic Submissions Gateway (ESG) and GUDID test account, validating the submission process and sending the test results to the FDA for approval of a production account. Fortunately, companies do not need to have HL7 SPL and xml gurus on staff to manage this, as third party submission providers and consultants are available to guide you in the process.
As Class II manufacturers near the compliance date, manufacturers who have met the earlier compliance dates offer lessons they have learned:
- Do not wait!! 24 September is the compliance date for both Labeling and GUDID.
- An hour of planning can save an hour of doing. Plan your project, prioritize and assign tasks, organize data.
- Divide and conquer – Depending on the organization, generally Labeling Engineers focus on label design, Regulatory, R&D and Marketing collect data, and Quality or Documentation Control handle the change control approval processes.
- A penny saved is not a penny earned. Don’t make the mistake of choosing the cheapest solution. It may cost less now, but will end up costing far more in money, time and resources later.
So to answer the question “What comes first – Labeling or GUDID?” I say “both.”