What it takes to achieve successful GUDID submissions?

In our earlier article on Class II Device UDI Compliance,we have emphasized more on how to identify FDA UDI requirements pertaining to your specific products and data.Though it helps Regulatory Professionals draw up a comprehensive compliance plan,knowing the nitty-gritty of regulatory rules and procedures alone won’t help organizations fall in line with successful compliance;it depends on how accurate and prepared are organizations not only while collecting and submitting the DI records to GUDID but also while managing the device reports post submission. Besides having a firm grip over governance pre-requisites, organizations need to follow a structured approach for successful submissions and compliance.

Here we explain four key steps to structure your UDI compliance roadmap along with corresponding challenges and solutions:

Diagrammatic Representation

Update DI records

Preparing DI records right at the time of compliance is anything but easy for regulatory professionals, in case an organization has a huge list of product portfolios.At that time, acquiring all the relevant information (device type, make model, etc.)distributed across the organization would pose a difficulty. In addition, validating the accuracy and completeness of collected data would also be quite challenging to cope up with error-free submissions.

In such scenarios, collecting and managing DI records using an enterprise process workflow would be of some use. Manufacturers need to follow a task based approach. Make different parties in your organization stakeholders for information collection wherein respective regulatory teams shall update the information management system with recent and final product information on a timely basis at regular intervals. Likewise, DI records would be updated perennially to avoid last minute hurdles for data aggregation for confident GUDID submissions.

Obtain HA acknowledgements

Once DI records are up-to-date, complete and accurate, regulatory managers may submit and publish them to FDA GUDID. Not to mention, the compliance is not yet done right after the submissions. Post submission, regulatory professionals shall constantly keep in touch with HAs to obtain device approval or rejection acknowledgements. The outcome would then be useful to plan a resubmission as per the proposed amendments, if any.

But the time being a critical factor for Class II device UDI labeling process,long intervals between obtaining acknowledgements would affect your device’s time-to-market.At that time, the best practice is to improve project management efficiency by maintaining a single version of truth medical device database enabled with electronic signatures. Doing so, it would be electronically feasible for regulatory experts to both review &approve DI records pre-submission and track &record FDA acknowledgements post submission.

Update Device Status

Device data submitted and acknowledgements received. What if the status is not updated to health authorities? Throughout the lifecycle, the core responsibility of regulatory professionals is to maintain and monitor the device status(approvals and rejections as well) to keep US FDA product registration up to date.However, lack of pre-defined data storage methodologies throughout the UDI implementation process would affect the traceability of device while updating status to HAs.

Hence, to enrich the traceability, regulatory professionals shall categorically store all device attributes in pre-formatted data models as defined by the US FDA in an enterprise-class medical device database. The data to be stored could be pertaining todevice, package details and other characteristics.

Build connection between Product Identifier (PI) records and Device reports

In case of any adverse events, or product recalls by the FDA, the manufacturer/labeler needs to send out information to the end user. The recall information is based on the PI and facilitates the recall.

The only way to build the connection is to enable information sharing across the enterprise with a centralized device information repository of the PI and (Device Identifier) DI records to enrich tracking and assessing the uniformity, accuracy, accountability of label identifiers etc.

This system will support traceability of medical devices especially for the field-safety corrective actions.

In conclusion

UDI implementation is a complex and time consuming process. During the course, while meeting with FDA’s UDI requirements, medical device manufacturers face many challenges pertaining to data aggregation, submitting DI records and managing device reports. With compliance deadline for Class II devices is drawing nearby, Freyr recommends that companies start working towards it right now.

To smoothly navigate your organization through this complex compliance process, Freyr offers the best of both worlds – on-demand, fully configurable, UDI software solution, Freyr IDENTITY, as well as a UDI Centre of Excellence (CoE) that offers best in class, cost-effective and customizable UDI services built around your unique and demanding requirements.