Friday, September 12, 2014

Accredited Issuing Agencies for UDI

As of September 2014, there are three issuing agencies for UDI that have been accredited by the FDA. Issuing agencies operate a system for assignment of UDIs.

The U.S. FDA UDI Final Rule indicates that not all product types need to have the same issuing agency, so medical device companies can use more than one.

Not all issuing agencies are accredited in other countries, so it’s important to review where each issuing agency is recognized if your products are sold globally.

Each issuing agency operates differently, so make sure you understand how your company would implement the standards for each agency.

FDA Accredited Issuing Agencies:


GS1
Date of Initial Accreditation: December 17, 2013
Initial Accreditation Granted through: December 17, 2016

Health Industry Business Communications Council (HIBCC)
Date of Initial Accreditation: December 26, 2013
Initial Accreditation Granted through: December 26, 2016

ICCBBA
Date of Initial Accreditation: February 12, 2014
Initial Accreditation Granted through: February 12, 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.

Wednesday, September 10, 2014

Data in the Cloud Can Be 21 CFR Part 11 Compliant

There is no doubt about the growing popularity of cloud computing.  Companies of all shapes and sizes are moving their data to the Cloud.  One big reason for the shift is the IT cost savings.

When it comes to life science companies moving their data to the Cloud, compliance with government regulations, such as 21 CFR Part 11 and Annex 11 are a major concern.  Healthcare and life science companies need regulatory compliance to be part of their cloud solution.

Healthcare and life science companies can take advantage of the benefits of cloud solutions without compromising regulatory compliance.  There are several cloud computing providers that ensure the authenticity, integrity and confidentiality of electronic records.  But, cloud vendors are not regulated, so healthcare and life science companies need to ensure their cloud computing system is compliant with government regulations.

USDM Life Sciences specializes in providing answers and solutions for life sciences companies looking to move their software and servers to the Cloud. In fact, many of the largest software and hardware companies in the world come to USDM Life Sciences for best practices in the Cloud.  As a recognized global leader in life sciences compliance, USDM Life Sciences’ cloud solutions provide security, lower costs and ensure compliance.

Monday, September 8, 2014

Do UPC Barcodes Fulfill UDI Labeling Requirements?

Class I medical devices marked with a UPC barcode comply with the requirements of the U.S. FDA Final Rule. The UPC number is used as the UDI. For class II and II, it depends on whether the device contains additional Product Identifiers (PIs) on the label or package.

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.

Friday, September 5, 2014

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.

Thursday, September 4, 2014

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.

Wednesday, September 3, 2014

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.

Tuesday, September 2, 2014

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.