A recent United States Food and Drug Administration (FDA) regulation, issued on September 24, 2014 has medical device manufacturers on a global basis, readying their organizations for compliance. The new regulation requires most medical devices to be marked and labeled with a unique device identifier (UDI) and then entered into the FDA’s Global Unique Device Identification Database (GUDID) with a set of FDA-specified attributes. Compliance dates are driven by the class of medical device. Many 1WorldSync customers are launching internal initiatives to drive compliance with the FDA regulation, as well as, implement improved information management practices for improved data quality and process efficiencies. Questions we find our customers asking themselves:
- What is the scope of products impacted?
- How can I source my data from multiple locations, formats and systems, controlled by different functions?
- How can I ensure the data I provide to the FDA is complete and accurate?
- How can I better understand and unlock the value of the GS1 Standards?
1WorldSync is helping medical device manufacturers and healthcare providers in several ways, including expanding adoption of GS1 Standards within their organization. There are 2 key areas for readiness to consider: Organizational Readiness and Data Readiness.
While at first blush, preparing data for submission to an external entity, particularly one like a federal agency, may seem daunting and nebulous, it doesn’t have to be. If you can engage the appropriate internal stakeholders and external sources to assist you, your organization can put together a framework that is leveraged at each step in the process from sourcing the information internally through distribution externally.
At 1WorldSync we assist our healthcare customers globally to think about 3 key areas for organizational readiness: Attribute Preparation, Data Quality and Business Process Design and Distribution, including propagation of product information into the FDA database. Each of these areas is worthy of a deeper dive. The focus of Business Process Design, and how it will help you ready your organization to share product information, is to establish and document business processes incorporating data distribution, item set-up and on-going changes. Once your organization has aggregated the data attributes, ensured the data is accurate, you will need a distribution model that easily populates GUDID.
Check back next time when we talk further on Data Quality via a quality assurance framework. Don’t forget to come and visit 1WorldSync’s Booth #205 at AHRMM 2014 in Orlando, Florida to find out more about UDI and how 1WorldSync can help you comply. #205.
NOTE: If you are a class III medical device manufacturer, you have less than 60 days to comply with this FDA regulation. If you need assistance in organizational or data readiness to comply with this legislation call 1WorldSync to find out how we can help at +1 866 280 4013
About 1WorldSync Healthcare Solutions
With the 1WorldSync healthcare offering, we provide a simple, but comprehensive solution to capture, manage and share your product information. 1WorldSync is actively empowering manufacturers to:
- PREPARE product information to be compliant to FDA UDI regulations
- CAPTURE and aggregate data across multiple countries and markets to ensure compliance with medical device regulations throughout the global supply chain, including International Medical Device Regulatory Forum (IMDRF)
- MANAGE product data from multiple entry points to ensure complete and accurate information
- DISTRIBUTE product information using a timely, manageable and auditable methodology
- Transforming the Global Healthcare Landscape - July 23, 2015
- Shifting paradigm in healthcare - August 20, 2014
- I’m not sure what UDI stands for, how will my Organization be ready for compliance? - July 7, 2014
- Mergers & Acquisitions in Foodservice and the impact to GDSN® - May 30, 2014