How Long Does it Take to Upload Files to Global UDI Database?

If you are using the GUDID Web Interface, it will take 10-15 minutes to enter all the data for one device identification record.  However, proficient users would likely be able to enter the data faster.

If you are using the SPL submission method, updates to the GUDID happen nightly.  So, if you submit a record today with a publication date of tomorrow, the record will be available on the GUDID tomorrow.

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.

Methods to Submit Data to the Global UDI Database

Web Interface:
The GUDID Web Interface supports submission, search and retrieval of device information through a secure web interface.  In order to submit device information to the database, you must first obtain a GUDID account.

SPL Submission:
SPL submission allows companies to electronically submit device information one device identification record at a time with an HL7 SPL XML file.  In order submit data using SPL submission, you need to create a GUDID account and use the FDA Electronic Submissions Gateway.  Companies will be required to complete GUDID testing prior to production submissions.

Spreadsheet Uploads:
Some of USDM Life Sciences’ UDI application partners have tools that enable data from spreadsheets to be uploaded to the GUDID.  Contact USDM Life Sciences to learn more about what GUDID submission solution is best for your company.

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.

Global UDI Database: What if a Product is Discontinued Before the UDI Compliance Deadline?

Data for a medical product that will be discontinued before the UDI compliance deadline is not required to be entered into the Global Unique Device Identification Database (GUDID), it is optional.  You can enter a begin distribution date and an end distribution date of today into the database.  You may want to add a product to the database that will be discontinued if the product has a long life or a long supply chain so the record exists in the database.

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.

Global UDI Database: What if a Medical Device is Discontinued?

It some point in the future when a product is no longer distributed, the medical device company will need to put a commercial distribution end date into the Global UDI Database (GUDID).  The product’s data will still reside in the database, but a flag will be set to let people know this product is no longer in distribution.  The product may still be in the supply chain and people may still own it, but medical device companies are required to add a date of when the product is no longer being distributed.

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.

Global UDI Database: What Verification or Validation Does FDA Need?

There aren’t any validation activities beyond what the database is doing inherently or through business rules.  There is no formal review of device data by FDA auditors or inspectors.  FDA does have a team of data quality experts who examine whether the instructions are clear and ensure data is coming into the database in a consistent manner.  Ultimately, FDA employees are looking to make sure the database is operating correctly.

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.

Benefits of Pharmaceutical Serialization

The Drug Quality and Security Act (DQSA) was enacted on November 27, 2013. The DQSA calls for a 10 year implementation plan to track pharmaceuticals as they make their way from the manufacturer to a pharmacy.

But, there is more to the serialization regulations than compliance. Pharmaceutical companies will gain many internal benefits by adopting a serialization system.

Product Authentication 
Serialization can prove a products authenticity, which means a manufacturer can detect and combat counterfeit products and ultimately protect their company brand.

Coordination of Supply Chain Data
Manufacturers can get information about products as they move through the supply chain. Supply chain visibility can help a company control inventory and reduce costs. Manufacturers can also see the impact of supply chain disruptions.

Efficient Recall Process
Manufacturers can conduct precise recalls by pinpointing locations that received the product in question.

Grow Revenue 
Reduce counterfeit activity that occurs when products are faked and diverted.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of 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 foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.

The Drug Quality and Security Act (DQSA) Will Hopefully End Counterfeit Medicine Problem in the U.S.

One goal of the Drug Quality and Security Act (DQSA) is to prevent counterfeit pharmaceuticals from getting in the hands of unsuspecting people because many of them don’t have the correct ingredients in them.  In fact, some of the ineffective medicines contain unsafe ingredients.

In January 2014, two people were charged with shipping fake cancer drugs to the United States, some of which authorities say were only vials of water and mold.

In February 2013, the FDA found a product labeled as an injectable cancer medicine, but there were no active ingredients in it.

In 2012, the FDA warned consumers about a counterfeit drug to treat attention deficit hyperactivity disorders (ADHD) and narcolepsy.  The FDA’s laboratory tests concluded the counterfeit version of the drug contained the wrong active ingredients.  Instead, the pills contained ingredients to treat pain.

The World Health Organization estimates that up to 10% of the pharmaceutical market is fake, much of it can be found on illegal websites that hide their geographic location.

The DQSA was signed into law by President Obama on November 27, 2013, which means pharmaceutical companies will be required to adopt an electronic system to identify and trace their medicines as they make their way from the manufacturer to a pharmacy.  Some of the requirements of the DQSA start on January 1, 2015.  Read more about the implementation timeline here.

USDM Life Sciences will help you assess, plan and execute the changes and enhancements necessary to meet these regulations. Our team of 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 foreign medical agency databases for pharmaceutical tracking. Also, USDM experts ensure that all changes and enhancements are implemented under the governing GMP regulations, under change control and validated prior to release for production.