by Scott Cook – Director of Quality and Compliance

How are you managing UDI within the FDA timelines and what steps are you putting in place to work with your medical device contract manufacturer?

The FDA has established a unique device identification (UDI) system to adequately identify medical devices. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human and machine readable form. Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). The goal is to improve patient safety, modernize device post market surveillance, and assist medical device innovation.

Key timelines to remember: FDA released UDI Final Rule and Draft GUDID Guidance for Industry September 24th, 2013.

GUDID data submitted to FDA and UDI on label:

  • Class III by September 24th, 2014
  • Implantable, Life-Supporting, and Life sustaining Devices by September 24th, 2015
  • Class II by September 24th, 2016
  • Class I by September 24th, 2018

The Challenges: Labeling for each manufacturer can vary dramatically across the gamut from label standards, format, content, data and systems are often not consistent across product lines, business units and manufacturing sites. Traditional label processes are prone to costly errors in compliance and production waste due to errors found during the manufacturing process. This can lead to fines and legal action if misbranded inventory is released to the market.

Addressing the Challenges:  A good place to start is looking at the design input stage of the development process to ensure that UDI compliant labels and GUDID submissions are addressed with new product introduction.  A strong product lifecycle management (PLM) platform and artwork management system (AMS) that allow all data to be stored and controlled in a compliant centralized location will be critical. Electronic product lifecycle management and quality management system (QMS) solutions may be key when it comes to integrating UDI to ensure that all product, labeling and UDI data is controlled from the product records, development, registration and change control across all product lines. Working with your manufacturer during this transition and implementation is paramount. Identifying your gaps and putting a well thought out plan for the future in place is critical to your success with UDI.