Cincinnati, Ohio – With September’s deadline for displaying unique device identifiers on high-risk devices just around the corner, rollout for many manufacturers is well underway. Yet questions remain about how the FDA will enforce the new requirements, says Steve Niedelman, an FDA veteran and lead quality and systems consultant at King & Spalding.
Under the UDI final rule, manufacturers are required to imprint a two-part code on a device’s packaging or, in some cases, the device itself. The device identifier lists the specific version or model of the device, while the production identifier more precisely identifies the specific device through information like lot/batch, serial number or expiration date. The company must submit all of that information to the FDA’s Global Unique Device Identification Database.
But the FDA has yet to explain how UDIs will be considered during device enforcement, Niedelman told a Wednesday session of the FDA/Xavier University MedCon conference. For example, will UDI violations be reported on Form 483s after inspections? And will warehoused devices returned due to lack of a UDI after several years in storage be considered a reportable recall?
And while manufacturers must create a new UDI anytime there is a new version or model of a device, it isn’t clear whether reviewers will look at the proposed UDI when they’re considering a device for approval or 510(k) clearance, Niedelman said. “There’s no official relationship to premarket approval, but it’s certainly going to be considered during premarket enforcement,” he added.
Niedelman noted that manufacturers of Class III devices can seek a one-year extension for displaying UDIs, but the request must be made by the end of June.
Exemption from UDI is possible, Niedelman said, but the FDA’s threshold for exemption is “rather high,” and the agency may rescind a waiver at any time. The FDA will list UDI-exempt products on its website.
To help prevent a backlog, the FDA is advising companies that obtain an exemption on one product and have others that may qualify on similar grounds to assume the exemption applies to those products as well, Niedelman said.
Devices intended for multiple uses, or for reprocessing, should be directly marked with UDIs, Niedelman advised conference-goers. However, reprocessors are not required to add new UDIs to refurbished devices. Devices that cannot be marked with UDIs due to technical or safety factors also are exempt, he said.
“If you have an exemption, just document it in the design history file,” Niedelman said. “The FDA doesn’t need to be notified.”
Niedelman had tips for manufacturers of medical apps as well. For software regulated as a medical device, the UDI should be displayed either when the program opens or as a pop-up window. Software sold on store shelves should also include a UDI on the packaging, he said.
Anytime a new version of the software is introduced, the manufacturer will need to create a new UDI. If the change affects safety, the lot number should be altered. For cosmetic modifications and minor bug fixes, a new production identifier should be sufficient, Niedelman said.
UDI requirements for devices sold in multiunit packages are another source of confusion, the consultant said.
For instance, a manufacturer selling a box of 10 bandages does not need to display the UDI on each individual bandage. But when the manufacturer uploads data about its products to the UDI database, each bandage must be noted. “Even though each bandage is not labeled, it must exist in the UDI database,” Niedelman said.
He added that combination products that carry New Drug Codes are exempt from UDI requirements. However, combination device components not covered by an NDC must bear a separate UDI.