The US Food and Drug Administration (FDA) has released new guidance regarding Unique Device Identification (UDI) compliance dates for Class I and unclassified medical devices. Effective immediately, the FDA has postponed GUDID (Global UDI Database) compliance for Class I devices by two years until Sep 24, 2022 due to COVID-19.
In this guidance, the FDA acknowledged that “preparing to implement UDI requirements while addressing the challenges related to Coronavirus Disease 2019 (COVID-19) could be very difficult and could divert resources from COVID-19 response efforts”. The FDA further stated, “To the extent this policy helps labelers remain focused on public health needs related to COVID-19, we believe the policy is further consistent with the public health.”
Innovit understands today’s immediate challenges facing the medical device industry – and certainly the worldwide impact of COVID-19. So, we welcome the FDA’s postponement of GUDID compliance for Class I which is expected to relieve pressure for key Medical Device manufacturers.
While manual data entry or Excel spreadsheet uploads may have been a viable solution for Class II and III submission deadlines, Class I poses a much greater challenge for manufacturers, labelers and hospitals. 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 entry into the GUDID. 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. (Note that Class III and Class II Implantable devices are mandated to require FDA approval.) Therefore, the risk of failing to meet the FDA’s deadline increases substantially.
GUDID & UDI – Are You Prepared?
The goal of GUDID & UDI is to help improve patient safety. For manufacturers, UDI will improve internal processes, bolster master data quality, and provide more accurate reporting and visibility related to product recalls and counterfeit devices. Unfortunately, manual submission methods via data entry or Excel spreadsheet uploads are time‑consuming and error prone. An automated, machine-to-machine solution will help medical device suppliers achieve compliance with UDI requirements for America, ensure data validation and submission, enhance master data quality and reduce operational & IT costs.
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 the 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 to prepare and start early for the UDI Class I Device Deadline of September 2022.