The FDA’s initiative to establish an authoritative Unique Device Identification (UDI) system for medical devices marketed in the United States is nearing its first significant milestone, but a number of manufacturers are behind in their efforts to comply with the new regulations.
The manufacturers of Class III medical devices must comply with the FDA’s final UDI rule, including successful data submission to the Global Unique Device Identification Database (GUDID), by Sept. 24, 2014.
The FDA’s Unified Registration and Listing System (FURLS) lists approximately 750 Class III medical device manufacturers; however, at a May 2014 UDI conference in Baltimore, the FDA UDI team reported that only 79 GUDID production accounts had been created. This information is the most recent publically released data from the FDA and more accounts may have been created. This data indicates that only about 10 percent of the affected device manufacturers have successfully created GUDID production accounts.
That leaves hundreds of Class III device manufacturers with fewer than three months to create a GUDID production account and submit their inventory of device records. Device manufacturers that do not meet the deadline are technically “misbranded” and at risk for enforcement actions by the FDA.
Reed Tech has been working closely with both the FDA and medical device manufacturers over the past year, putting our GUDID compliance solution in place. The firsthand knowledge we have gained through this experience demonstrates how quickly time is running out for Class III device manufacturers.
“If you are one of those Class III device manufacturers in the early stages of GUDID compliance activities, it is imperative that you move forward quickly,” said Gary Saner, Senior Manager of Information Solutions – Life Sciences at Reed Tech. “Each of the steps in a GUDID compliance plan takes time.”
For example, all manufacturers must first request a GUDID pre-production account from the agency. The Account Request Form requires detailed information that may require some investigation and internal corporate approvals. From our experience, the FDA can take up to a week to reply to the submitted Account Request Form, Saner said. Another day or two is required to create user accounts and receive credentials back from the FDA.
If device records are submitted electronically via the Electronic Submissions Gateway (ESG), then an ESG account must also be set up, requiring up to six weeks’ time depending on the electronic submission method chosen and the support from your internal IT department. Once established, the ESG account is used to submit Structured Product Labeling (SPL) test files for four test scenarios. The FDA is manually administering the testing so additional days are necessary for the pre-production test process. Upon successful SPL test submissions, a production GUDID account is requested and granted by the FDA.
“We’ve observed multiple weeks for a manufacturer to setup a GUDID pre-production account and finish SPL testing. And, as it gets closer to the deadline, it may even be longer,” said Saner.
Some device manufacturers are hoping that, if industry is slow to comply with the regulations, the FDA will extend the deadline. The FDA has given no indication that an extension will be granted and betting that the deadline will be extended leaves a manufacturer open to serious repercussions if the deadline is missed.
At Reed Tech, our GUDID compliance solution is already established and was built upon our nine years of pharmaceutical SPL submission experience. Our subject matter expertise and our tested and validated software allow device manufacturers to meet GUDID compliance on time. If a manufacturer uses the Reed Tech solution, the times mentioned above for setting up accounts are significantly reduced, making the Sept. 24 deadline easily accomplished.
Device manufacturers have a choice: some may want to use our GUDID Software as a Service (SaaS) model, which allows client users to directly manage the data flow, e.g., collect data electronically, approve records, build SPLs, and submit them to the FDA GUDID through the ESG. Other manufacturers may want to engage our GUDID Outsourced model where clients simply provide the source data to us and Reed Tech UDI specialists manage the data flow through final FDA GUDID publication. Both models employ the same robust Reed Tech data validation engine, database versioning and storage, and automated AS2 connection for ESG submissions.
“Our solution is ready to go as soon as the client is ready to submit the data,” Saner said. “Whether a manufacturer chooses SaaS or the Outsourced model, they can be submitting data after a short system configuration.”
To find out more about how the GUDID solution from Reed Tech can help your company achieve UDI compliance on time, contact us today.
- Read more: “Lessons Learned: GUDID Submissions”
- Learn about Reed Tech Medical Device UDI / GUDID Submission Solutions