HIDA Government Affairs Update
Linda Rouse O’Neill
By Linda Rouse O’Neill, Vice President, Government Affairs
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.
Best practices
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 partners.
- 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 provider customers.
- 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 customers.
- Continued dialogue. Distributors and manufacturers should maintain an open dialogue to ensure that UDI requirements are met as customer needs change.
Background
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.