FDA Class I GUDID Compliance Regulation FAQ’s
We held a webinar last week titled, ‘9-Steps to GUDID Class I Medical Device Compliance’ and received a number of great questions from our attendees.
We thought it’d be helpful to put these FAQs in a blog and ensure everyone has answers to questions around FDA’s GUDID Class I Compliance. If you have additional questions, please feel free to reach out to us! We’re here as a trusted resource to support you on the journey to GUDID Class I compliance.
- What are the FDA’s goals for the Global Unique Device Identification Database?
The FDA’s goal is to strengthen public health with standards that ensure patient safety, data security and reliability. The Global Unique Device Identification Database (GUDID – pronounced as “Good ID”) will serve as a reference repository for every medical device placed for sale in the US market. The UDI system allows medical devices to be identified with a unique device identifier (UDI), providing a better label to describe what they are, and what they are used for, across the healthcare supply chain.
- What are the requirements for Class I medical devices relating to UDI data submission to the FDA’s GUDID?
Class I devices, and devices that have not been classified into class I, class II or class III that are required to be labeled with a UDI, must bear UDI as a permanent marking on the device itself – if the device is one that is intended to be used more than once and intended to be reprocessed before each use. §801.45
On July 22, 2022 The U.S. Food and Drug Administration (FDA) issued a Final Guidance document for labelers of Class I medical devices. In an effort to help the industry remain focused on high-quality Unique Device Identification (UDI) submissions and COVID-19 response efforts, the agency announced it does not intend to enforce standard date formatting, UDI labeling and GUDID data submission requirements for Class I and unclassified devices before December 8, 2022. (Previously September 24, 2022).
- Are there any exemptions to GUDID compliance?
Yes. The FDA has provided exemptions for devices qualifying as consumer health products, which are defined as “510(k)-exempt Class I devices, sold directly to consumers over-the-counter in brick-and-mortar and/or online stores.” Although exempt, these devices must still carry UDI data on their labeling and packaging. Other scenarios may require compliance.
- Are there regulations that require vendors to sell products by UDI vs vendor catalog number?
Unfortunately, No. FDA regulations do not apply to this level of activity. We see continued use of catalog numbers for this purpose. Many industry participants thought catalog numbers were a bridge to UDI, and with the 9-year implementation time frame, most had assumed there would be a transition period where we would migrate away from catalog numbers, but we’re not seeing this. In fact, catalog numbers are becoming more entrenched. We think we’ll eventually get there, but right now people are still using catalog numbers to sell products. Today, both UDI and catalog numbers are being used as a product identifier. We hope that the industry will migrate away from catalog numbers as these are not unique, whereas unique device identifiers (UDI) are.
- Do all current, established Class I devices require a UDI code if the lot number and date of manufacture is on the label?
Yes. The concept of existing inventory (and the three-year existing inventory construct) that was present during the implementation of the regulation is now gone. The compliance date did not change with the enforcement of the regulation. Therefore, any inventory and/or any device that is being commercially distributed at this point needs to be UDI compliant.
- When testing GUDID submissions, are you actually scanning the barcode to test that as well?
We’re not scanning barcodes when we’re testing data submissions to the GUDID. We’re testing to make sure we have connectivity and authorizations in place in order to transmit data to the FDA. You will find that your issue agency (GS1 or HBICC) will offer testing services for you and give you a barcode verification report.
Innovit’s system provides the attribution, code lists and validation rules required to ensure that your product data is compliant with UDI regulations. Our customers populate Innovit’s software with the required data elements, then we submit all validated product data to the FDA on your behalf.
- Can data submitted to the FDA be corrected?
Innovit does all the data validation required by the FDA, but it is possible to provide incorrect, but valid, UDI data to the FDA. Any data element can be corrected or changed as long as it’s one which is locked after the grace period. Alternatively, a UDI record can be terminated, and a new ‘substitute’ record created.
- What are some of the advantages and disadvantages of manual entry by companies instead of using Third Party Submitters?
- Data Validation and Quality: We test our systems rigorously with the FDA so we know your data is fully validated before it is submitted to the GUDID. Knowing the validation errors you have with your data allows you to correct those issues before submission, which helps minimize the number of error messages coming back from the FDA.
- Ongoing Support: Innovit offers real-time helpdesk support to guide you through the process – end-to-end. We also provide online support, user guides and recorded training classes and tutorials. We’ve prepared lots of user guides to help you collect the necessary data and ensure it is valid the first time you submit.
- Error Handling: Invariably we all have internet outages, and AS2 messaging gateways dropping messages. When these issues arise from either the FDA or in your system, we can help you track down the issues.
- Cost: Innovit’s systems do cost money. We invest to ensure that our systems are validated to GAMP5 standards, and 21 CFR Compliant. In addition, Innovit is constantly training our support desk experts to understand emerging UDI regulations all around the world.
- How do I know if it makes sense to partner with a third-party submitter like Innovit on my UDI journey?
At the end of the day, the cost benefits analysis depends on (i) how much data you have to submit, (ii) how often you are required to do UDI submissions and, (iii) how many countries you plan to do business in that have implemented UDI requirements. If you’re looking to do business outside of the US and research evolving UDI requirements on a global scale, manual data entry & submissions become increasingly difficult to manage. The more data you have and the more frequently you do submissions, the more compelling your business case for using a third-party submitter becomes. It’s also important to remember that your company will experience staff churn — people come and go — so using a third-party system provides continuity for all your UDI processes.
- Are all Class I exempt devices, such as adult products, required to be submitted to the GUDID?
Yes, although your device may qualify as “exempt”, there are many reasons you should still strive to put your data into the GUDID system. The database is intended to be the catalog of all medical products in the United States. There are many companies and consumers pulling this data, so it’s very important to get your data included in the comprehensive GUDID system.
Innovit is here to help you on the path to regulatory compliance and we’re ready to help you prepare and meet the new GUDID deadline of December 08, 2022 for risk Class I devices.