Optical Medical Device Manufacturers – GUDID & UDI – Are You Prepared?

Global Ophthalmic Medical Devices – Meeting Market Demands

According to the Vision Council of America, approximately 75% of adults use some sort of vision correction.  With the increasing adoption of contact lenses and spectacles, coupled with the rising number of retail chain stores, optometrists and opticians, the global vision care devices and equipment market was valued at about $27.6 billion in 2018 and is expected to grow to $33.68 billion at a CAGR of 5.1% through 2022[1].   And when you factor that an estimated 2.2 billion people around the world need vision correction but over 1 billion don’t have access to such eye care[2], that’s good news for optical medical device manufacturers.

Meeting these aggressive market demands will require innovative approaches to production and leveraging the supply chain for a competitive advantage.  But in order to do so, it also requires that optical medical device manufacturers meet regulatory and compliance requirements for product data submissions.

Regulatory Requirements – Submitting Product Data

The FDA’s UDI regulations for Class I devices require labelling, direct marking and GUDID submissions are due September 2022.   Note that Class I devices include spectacle frames, Plano sunglasses, over-the-counter reading glasses and many low vision devices.[3]  Additionally, for those manufacturers intending to market prescription eyewear products in the European Union, EUDAMED submission will be due in May 2022.

Additional global regulators are emerging and will require regulatory expertise for UDI submissions.  The challenge of course in meeting these regulations is that product data must be accurate, complete – and most importantly – “trusted”.

Submitting Product Data – Taking a Closer Look

The sheer volume of products in this category makes manual submission methods too slow. High product volume increases the burden of data collection, data cleansing and data submission to the GUDID (Global UDI Database).  In addition, Class I products tend to change more frequently due to a constant flow of new models and variants.  These products do not require long cycles of clinical trials and performance studies.  Therefore, the risk of failing to meet the FDA’s deadline increases substantially.

GUDID & UDI – Are You Prepared?

The goal of UDI regulations is to help improve patient safety.  The GUDID system was designed by the FDA to facilitate product information exchange between ‘labellers’ and hospitals.  For manufacturers, UDI will improve internal processes and bolster master data quality.  It will also provide more accurate reporting and traceability during product recalls and track down counterfeit devices.  Unfortunately, manual submission methods via online data entry or Excel spreadsheet uploads are time‑consuming and error-prone.

An automated, machine-to-machine solution will help optical medical device suppliers achieve compliance with UDI requirements for America in an efficient and cost-effective manner.  Additionally, data validation and submission can be systematically assured, and master data quality can be improved significantly without increasing operational & IT headcount.

It’s Time to Ask…

  • Have you identified the scope of Class I products impacted?
  • Is your data sourced from multiple locations?
  • Is your data accurate and complete?
  • Do you have a formal data governance strategy?
  • Do you have a sustainable process to provide accurate product data to the FDA?
  • Do you have a primary source of truth for product information?
  • Can your product master data be ‘trusted’ by your customers and regulators?
  • If you’ve answered ‘No’ to any of these questions, it’s time to establish a primary source of product information to ensure that master data you share with the FDA can be trusted and accurate.

Schedule a complimentary consultation to understand more about how to prepare and start early for the UDI Class I Device Deadline of September 2022.

[1] https://www.businesswire.com/news/home/20191112005955/en/Global-Vision-Care-Devices-Equipment-Market-Report

[2] https://www.seattletimes.com/nation-world/new-focus-on-global-need-for-eyeglasses/

[3]https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfPCD/classification.cfm?start_search=251&Submission_Type_ID=4&DeviceName=&ProductCode=&DeviceClass=1&ThirdParty=&Panel=&RegulationNumber=&PAGENUM=50&SortColumn=RegulationNumberDESC