Low-unit-of-measure (LUM) and just-in-time (JIT) programs are popular
with providers, but they can create a headache for compliance with the
Food and Drug Administration’s (FDA) unique device identifier (UDI)
rule. For example, a manufacturer may sell a product by the case,
whereas distributors break the cases into boxes or even eaches based on
customer needs. While the manufacturer’s original packaging will possess
UDI-compliant labeling, smaller batches or eaches of the product may
not have the necessary labels, and distributing these smaller units
through a LUM or JIT program to providers would risk non-compliance with
the UDI rules.
To help distributors and their trading partners meet this challenge,
HIDA has prepared a list of best practices for ensuring their products
meet the FDA’s requirements as they move through the supply chain in LUM
and JIT programs.
Communications between trading partners is key for maintaining UDI
compliance. Manufacturers need a clear understanding of the services
distributors offer so they can appropriately package and label their
products. To facilitate this communication, distributors and
manufacturers should follow these steps:
- Initiate trading partner discussions. The
distributor needs to make sure the manufacturer fully understands the
JIT or LUM program they offer. Due to anti-trust concerns, these
conversations must be conducted one-on-one between individual trading
- Share key data. The distributor must then share a list of products distributed in their LUM or JIT programs.
- The manufacturer reviews the distributor’s data and gathers
up-to-date UDI implementation plans from their product teams. The
manufacturer then determines if there are any gaps in UDI compliance
because of the distributor’s programs.
- The manufacturer presents the distributor with a plan for how
products can remain UDI-compliant when they are sold via a LUM or JIT
program. During this step, the manufacturer may require additional
information, and the distributor may need to gather input from their
- Develop a plan. In this step, manufacturers and
distributors decide on how to implement the necessary changes to comply
with UDI requirements, and how to communicate necessary information to
- Continued dialogue. Distributors and manufacturers
should maintain an open dialogue to ensure that UDI requirements are met
as customer needs change.
On September 24, 2013, the FDA issued the UDI rule. The rule applies to
most medical devices, and requires that they have a label on the
packaging or the product itself that can be used to identify key product
information. Due to the complexity of this rule, the FDA has created
several exceptions and extended certain deadlines.
These exceptions and extensions have been vital for HIDA members as
they work to comply with these regulations, and have given HIDA the time
needed to develop the above best practices.
These best practices are one of several resources on UDI compliance
that HIDA can offer. To learn more about these guidelines, or for more
information about UDI requirements, feel free to contact us at HIDAGovAffairs@HIDA.org.