Do Manufactured Parts for Medical Devices Need a UDI?

If you are manufacturing and selling a part of a medical device to another manufacturer (not a complete device), the package does not need a UDI.  However, the fully assembled device will need a UDI for distribution.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Are Lancets Included in the UDI Final Rule Single Use Packaging Exception?

Single use lancets are included in the single use packaging exception.  A single use device is not required to have a UDI on the package if it meets the following criteria:

• Device is distributed inside a package with more of the same devices. (The package that contains multiple single use devices is required to have a UDI.)
• Device is intended to be stored in the package with more of the same products until use
• Singe device is not intended for distribution
• Device is not considered an implant by the FDA

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

UDI Compliance: What Does a Medical Device Manufacturer Do With Devices Already Distributed?

The FDA’s UDI Final Rule is not retroactive, meaning it does not apply to devices that were distributed before the compliance deadline.  However, existing inventory (at manufacturing site, distribution center or on consignment) needs to be sold or comply with the UDI Final Rule by September 24, 2017.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

How Do I Know if a Class II Device Needs to be UDI Compliant by September 2015 (FDASIA) or September 2016?

Medical devices classified as implantable, life-saving and life-sustaining by the FDA must be UDI compliant by September 24, 2015.  The FDA lists every medical device by product code that must be UDI compliant in 2015 on this list.  If the class II medical device is not on the list, it does not need to be compliant until September 24, 2016.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

UDI Compliance: How Do I Know if My Kit Can Take Advantage of the Convenience Kit Exception?

If you place a UDI on a kit, you do not need to place a UDI on the components in it. However, the manufacturer still needs to have traceability of the components in the kit with the UDI. If there is a problem, the company must know which devices are inside the kit, so it knows which kits to recall. Although this is a UDI exception, medical device manufacturers still need to maintain control, visibility and traceability of the components with the UDI on the kit.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

UDI Compliance: How Does the Single Use Device Packaging Exception Work?

A single use device is not required to have a UDI on the package if it meets the following criteria:

• Device is distributed inside a package with more of the same devices. (The package that contains multiple single use devices is required to have a UDI.)
• Device is intended to be stored in the package with more of the same products until use
• Device is not intended for distribution
• Device is not considered an implant by the FDA (Check this list to see if the FDA considers your device an implant.)

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

UDI Compliance: What Parts of a Medical Device Need a UDI?

Any individual accessory or component that a manufacturer puts into commercial distribution must have its own Unique Device Identifier (UDI).  Spare parts for devices do not need a UDI.  An important part of the UDI compliance process is to determine which components and accessories are spare parts and therefore do not need a UDI.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

UDI Compliance: What is a Unit of Use DI? When is it required?

The Unit of Use Device Identifier (DI) is a requirement of the Global UDI Database (GUDID).  A Unit of Use DI refers to a product within a package that is not marked with its own Unique Device Identifier (UDI).  For example, an individual bandage in a box of 10 will need a Unit of Use Identifier.  When you submit data for the box of 10 bandages to the GUDID, you will be required to submit a virtual identifier called the Unit of Use DI for each bandage.  Because the identifier is virtual, you are not required to physically place a Unit of Use DI on each bandage within a package.  The Unit of Use DI is a method to discuss, describe and document a single bandage in the GUDID.


USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

UDI Compliance: Do Class I Medical Device Manufacturers Need to Do Anything Yet?

Class I medical devices don’t need to be UDI compliant until September 24, 2018. Jay Crowley, former Senior Advisor for Patient Safety in the FDA’s Center for Devices and Radiological Health and Vice President of UDI Solutions and Services at USDM Life Sciences, encourages manufacturers of class I medical devices to begin to understand UDI compliance and start to put a plan in place.

Many class I medical device manufactures will need new computer systems or additions to Product Lifecycle Management (PLM) and Product Information Management (PIM) systems. The selection and validation process for new systems can be time consuming.

Medical device manufacturers that distribute class I products outside of the United States should consider meeting the UDI compliance deadline early because some countries will require UDI compliance before the U.S.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.

Exceptions to the UDI Compliance Deadline

Medical device manufacturers can ask the FDA for an exception to the UDI compliance deadline.  Several medical device manufacturers have asked for and received an exception because of compliance difficulties.  Any exception to the UDI deadline requires the medical device company to have a compliance plan and date of when the company plans to be UDI compliant.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet UDI regulations. Our team of UDI experts will assess your products, the markets where they are sold and determine an implementation strategy for the changes that need to be made. USDM’s assessment methodology is extensive and includes the labels and packaging, the management of identification changes to each product, the changes to PLM, ERP, EPCIS and packaging systems, changes to printing, vision inspection and warehouse/inventory management systems and interfaces to the GUDID.