Some medical device manufacturers seeking to comply with the FDA’s final rule on Unique Device Identification may want to turn to outside firms for help throughout the process. Others may already have the expertise in-house to handle their UDI compliance and FDA GUDID submission needs, but require a tool to manage the data submission process.
The two primary components of any GUDID submission solution are a platform and manpower. For companies with a small product portfolio, the “platform” may be the FDA GUDID Web Interface. Some companies may develop custom software solutions, providing both the platform and manpower, to meet their larger GUDID data submission needs. For many manufacturers, however, an on-demand software solution, licensed from a third party and operated by the device labeler, is the best answer.
As the industry has evolved to meet the new workflows required for UDI compliance, solutions have been developed that will collect data electronically, build the Structured Product Labeling (SPL) submission document, and submit it to the FDA through its Electronic Submissions Gateway (ESG).
Companies looking for a third party tool may wish to consider a Software-as-a-Service (SaaS) solution. In the SaaS model, the labeler gathers the required data internally and manages the GUDID submission process using a cloud-based software tool developed by a third-party vendor. A comprehensive GUDID submission tool imports data, performs data validation, supports corrections to reported errors, builds and submits the SPL, and processes the FDA acknowledgments – all within a compliant workflow environment. Labelers do not need to worry about installing, validating, or updating the software on their own systems. In addition to a quick startup, the development and maintenance costs of a SaaS system is shared across multiple companies using the system.
When choosing a GUDID solution vendor, medical device manufacturers will want to evaluate how much experience that provider has working with the FDA and creating SPLs for bulk electronic submissions through the ESG. Reed Tech has been processing regulatory data and submitting SPLs since the FDA first adopted SPL as standard in 2005.
We have successfully made over 500,000 UDI record submissions to the GUDID. Contact Reed Tech for a free demo of our SaaS GUDID submission tool, or to learn more about our outsourced GUDID services. Email: MedDevice@ReedTech.com