Thursday, June 26, 2014

Do Medical Device Parts Need a UDI?

A commercially distributed part of a medical device does need a Unique Device Identifier (UDI).  Parts for medical devices used for repairs that are not commercially distributed 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.

Wednesday, June 25, 2014

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.

Tuesday, June 24, 2014

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.

Monday, June 23, 2014

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.

Wednesday, June 18, 2014

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.