While medical device manufacturers prepare to comply with the new Unique Device Identification (UDI) requirements, the Food and Drug Administration (FDA) is preparing to introduce a powerful new industry and consumer resource that utilizes all that data: the Global Unique Device Identification Database, or GUDID.
Together with the UDI regulations, the GUDID is expected to increase patient safety and healthcare system efficiency. However, for device manufacturers, compliance is likely to be time-consuming, especially initially.
Device manufacturers will be required to submit substantial amounts of information – 55 data fields for each individual product SKU they offer, plus another seven data fields from the FDA. When published, the final database will be freely available to the public via a website comparable to the National Library of Medicine’s DailyMed database of drug SPLs.
GUDID submissions present a substantial investment of time and resources that grows in relation to a company’s product portfolio. Manufacturers of Class III medical devices have just a few months in which to choose a GUDID solution; submissions are due by Sept. 24, 2014. Choosing the method by which they will submit their data to the GUDID, therefore, is a pressing question for most medical device makers.
Data may be submitted to the FDA using one of four methods:
GUDID Web Interface
The FDA has made available a free GUDID Web Interface, which enables device manufacturers to manually enter UDI data directly into the database through a secure online portal.
Users first need to create a free GUDID database account using either version 9 or 10 of the Internet Explorer web browser or a current version of Mozilla Firefox. The GUDID interface does not currently support Google’s Chrome browser.
Though using the GUDID Web Interface is free, each company will need to fund the cost of data entry and the employee hours required to complete it. The absence of a direct price tag may be tempting to companies whose UDI compliance budget doesn’t afford them as much flexibility as they might wish.
In practice, however, using the GUDID Web Interface to enter UDI information likely is practical only for small companies with a narrow slate of product offerings. Even mid-sized manufacturers likely would find the task too onerous for staff whose time probably would be better spent elsewhere. Data entry errors also are a concern, as is the prospect of having to manually update records in multiple places any time the required information changes.
Developed or Purchased Software
Some of the largest companies affected by the new requirements have responded to the looming deadline by developing or purchasing UDI compliance software solutions. These systems will allow manufacturers to bring their existing product catalogs into compliance and to accommodate future needs as their product offerings continue to expand. This investment of time and resources, however, is quite expensive and is out of reach of most small and medium-sized companies.
The two primary components in any UDI compliance solution are a platform and manpower. In the first option above, the platform is the FDA GUDID Web Interface and each company provides its own manpower. A developed or purchased software solution requires companies to provide both the platform and the manpower.
Two options lie between the two extremes outlined above, and both involve a degree of outsourcing. A number of vendors, including Reed Tech, have launched fully developed platforms for GUDID compliance that are available to medical device manufacturers. One is a SaaS service, while another is a hosted service.
Software as a Service (SaaS)
Device manufacturers with more than a handful of products have a larger volume of data with which to contend. They would benefit from software that will collect data electronically, convert it into the Structured Product Labeling (SPL) format required by the FDA, and submit it to the FDA through the Electronic Submissions Gateway (ESG).
Under this approach, companies utilize the software from a company such as Reed Tech but still supply the manpower required to actually perform the work. This UDI solution is helpful for high-volume electronic submissions to the GUDID where companies input the initial data and maintain it over time.
Other companies may choose to outsource their entire GUDID submissions project to a third party that has the infrastructure, capabilities and subject matter expertise to perform the work. Under this approach, device manufacturers hire an outsource provider with a UDI compliance solution, such as Reed Tech, and provide their device data for processing and submission to the FDA. The service offered by Reed Tech also verifies that the submissions are accurate and creates a database of company product information that can be updated easily in the future as devices information changes, new information is added or deleted.
Choosing which GUDID submission approach will work best for your company will require a careful analysis of the time and expertise that your in-house team possesses as well as the services and costs associated with some level of outsourcing.
Please contact us with any questions you may have about the options you have for submitting to the FDA’s GUDID.