UDI Compliance: Standardized Date Format Requirement

The U.S. FDA UDI Final Rule requires all dates on labels to be in the standardized date format (YYYY-MM-DD).  The Final Rule also requires a day be specified in the date.  Dates on labels must be in the standardized format by the time the device is required to be compliant with the Final Rule.

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 Format Does the Unit of Use DI Need to Be?

The Unit of Use Device Identifier (DI) must be the same format and from the same issuing agency as the Primary DI. So, if your company uses GS1 for labeling and you apply a G10 to the primary DI, then your Unit of Use DI also must contain a G10.

The Primary DI is the identifier on the label of the package. The Unit of Use DI is the identifier on devices inside the package, if there is more than one device inside. Unit of Use DIs only apply to devices subject to the Unit of Use DI.

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.

What Data Needs to be Included on Unique Device Identifier (UDI)?

A UDI is a unique numeric or alphanumeric code that consists of two parts:

• Device Identifier (DI): a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device.
• Production Identifier (PI): a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
• lot or batch number within which a device was manufactured;
• serial number of a specific device;
• expiration date of a specific device;
• date a specific device was manufactured;
• distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device

From fda.gov

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.

What are the UDI Compliance Requirements for Stand-Alone Software?

Stand-alone software must comply with the FDA’s UDI Final Rule.  But, there are special requirements for stand-alone software distributed virtually because there isn’t a package where a UDI label can be placed.  The UDI data must be in plain text on a “help” or “about” screen.  Software distributed on a CD, DVD or USB flash drive must have a UDI on the label of the device.

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.

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.