FDA Offers Extension For Some UDI Implementation Deadlines
The U.S. Food and Drug Administration (FDA) is giving original equipment manufacturers (OEMs) some additional time to remove legacy FDA labels from medical devices, citing concerns from payers and pharmacies that removing the labels prematurely would interfere with patient access. Certain medical devices manufactured before September 2018 will have until September 2021 to remove the legacy labels.
In order to create a more centralized location for the most up-to-date information available for commercialized medical devices, the FDA has implemented a unique device identification (UDI) system that will issue a two-part UDI number to certain medical devices, which can be used to reference labeling information and updates in a global database.
Since launching the system in 2013, the FDA has provided a seven year roll-out plan based on device classification, but the process has proven more difficult and time-consuming than originally imagined, and the agency has issued several deadline extensions for certain devices, including some orthopedic implants and intraocular lenses.
In a new guidance, the FDA has eased up on deadlines by which OEMs were expected to remove National Health Related Item Code (NHRIC) or National Drug Code (NDC) numbers — referred to as legacy FDA numbers — from their medical devices, once the UDI code was in place.
“The rational for these provisions is that continued use of NHRIC and NDC numbers on device labels and device packages could cause confusion regarding appropriate identification of the device or obscure the distinction between drug and device identification system,” said the FDA.
Payers and pharmacies often rely on the legacy FDA numbers for reimbursement and have argued that transitioning to UDI numbers too quickly could disrupt supply chain and procurement, and could potentially limit patient access to life-saving devices. In response to their concerns, the FDA has shifted the original 2018 deadline to 2021 for certain devices, saying “the risk of confusion is outweighed by the threat” of these disruptions.
The FDA stipulates that class III devices, devices listed under the Public Health Service (PHS) Act, Class II devices, and implantable, life-supporting or life-sustaining devices will be given extra time to make the transition away from legacy labels, but all other existing deadlines for other UDI requirements will remain in place.
OEMs and other industry stakeholders will have 60 days or until April 5, 2016 to comment on the guidance before it is finalized.
In a Q&A last September, Jay Crowley — VP of the UDI Practice at USDM Life Sciences — told MDO that there was a lot to learn about the first wave of UDI deadlines and offered some tips to OEMs still moving through the process. According to Crowley, many companies are making UDI implementation more difficult than it needs to be.
“Instead of a relatively small label alteration, complete changes are being made,” said Crowley. “May argument against these approaches is that they can increase the complexity, duration, and cost of execution. Implementing UDI is going to be a challenge for your company, why make it harder?”