FDA pushes back deadline for removal of legacy identifiers to 2023

Regulatory NewsRegulatory News | 20 May 2021 |  By 

After receiving pushback from industry, the US Food and Drug Administration (FDA) on Thursday said it will give medical device makers two more years to remove legacy identification numbers from their product labels and packages.
Under FDA’s 2013 unique device identification (UDI) final rule, medical device labels and packages are required to bear a UDI according to the schedule set in the final rule, with some exceptions and alternatives for certain devices. The UDI Rule also includes a provision to rescind National Health Related Item Code (NHRIC) and National Drug Code (NDC) numbers assigned to devices once UDI provisions are applicable to them.
FDA has since delayed enforcement of several UDI-related provisions, most recently in June 2020 when the agency extended deadlines for certain Class I and unclassified devices. (RELATED: Guidance: FDA holds off on enforcing certain UDI requirements, Regulatory Focus 30 June 2020).
This is the second time FDA has delayed its enforcement of the prohibition on NHRIC and NDC numbers for device labels and packages after extending its original deadline of 24 September 2018 by three years to 2021. (RELATED: FDA pushes back enforcement of UDI Rule provisions, Regulatory Focus 29 August 2016).
In a newly issued immediately effective guidance that supersedes the agency’s 2016 enforcement policy, FDA said it will not object to the use of NDC and NHRIC numbers on device labels and device packages for finished devices that are manufactured and labeled prior to 24 September 2023.
With the previous deadline approaching in a matter of months, industry associations and device makers, including AdvaMed, the National Association of Chain Drug Stores (NACDS), the American Diabetes Association, Dexcom and Insulet called on FDA to once again delay enforcement in comments submitted to the 2016 public docket this year.
“Removal of [NDCs] from medical device labels, which is required to occur beginning September 2021 pursuant to the [UDI] Rule, will significantly disrupt patient access to critical medical products and jeopardize public health. This includes the millions of Americans with diabetes who rely on the NDC for the processing and dispensing of devices used to manage diabetes, which include, for example, glucose sensors, strips, monitors, meters, syringes, lancets, and insulin pumps,” AdvaMed wrote in its comments.
AdvaMed and other commentors also cited the COVID-19 pandemic as an ongoing source of disruption to many of the players involved in the switch from legacy identifiers to UDI.
“The COVID-19 pandemic and public health emergency (PHE) has disrupted chain pharmacy operations to the point that most, if not all, pharmacy chains have had to temporarily postpone all previously planned technological and operational systems upgrades,” NACDS wrote.
Hearing industry’s concerns, FDA said it believes that “extending the policy for a limited additional time as stakeholders continue to make changes to transition medical device reimbursement, supply chain, and procurement systems and processes away from use of legacy NHRIC and NDC numbers is appropriate and in the interest of the public health.”
FDA further explains that because more devices will require UDIs by September 2024, it anticipates that healthcare systems and supply chains will be more equipped to rely on UDIs by that time.
Guidance, Federal Register Notice


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