With the New Year almost upon us, the FDA’s GUDID compliance deadline for Class I medical devices must now be met with urgency. September 24, 2022 is just around the corner!
In an effort to help the industry remain focused on COVID-19 response efforts, while still providing high-quality UDI data submissions, in July of 2020 the FDA announced a two-year postponement of its enforcement date for UDI labeling and GUDID data submission requirements for Class I and unclassified devices – until September 2022.
Time certainly flies – and the new year is fast approaching! How is your company prepared to aggregate, validate and submit your regulatory data for your Class I medical devices?
If you haven’t taken action, make it your new year’s resolution to take the first steps toward easy data compliance by following these steps:
- Identify the scope of Class I products impacted and review UDI guidance documents and resources to create an internal action plan for preparing your regulatory data for GUDID submission.
If you haven’t yet identified which products are impacted, do that immediately. A Class I medical device, are those devices that have a low to moderate risk to the patient and/or user. As of today, it’s estimated that 47% of all medical devices fall under this risk class. Identify the scope of Class I products impacted as soon as possible!
- Evaluate if you have a sustainable process to submit accurate product data to the FDA.
An established UDI process and a validated product data management system are valuable assets in meeting this business critical compliance deadline. Your investment in building a robust master data management process, and in choosing the ‘right’ PIM system for regulatory compliance is that it will scale to support other regional medical products regulators that are implementing UDI regulations in 2022 and beyond (for example, EU Commission, China NMPA, South Korea MFDS, UK MHRA, Brazil ANVISA, Australia’s TGA, etc.). It’s important to ensure that your company is not being shortsighted in solving for just the immediate challenge of GUDID Class I compliance, but look beyond the impact of US toward global UDI compliance requirements coming up.
- Determine if your product master data can be ‘trusted’ by your customers and the regulators.
If your data is sourced from multiple sources, this might be a problem. Further, do you know if you have complete and accurate data? Without a formal master data governance strategy, your data is likely to be inaccurate or out-of-date.
- Establish a primary source of product information to ensure that the master data you share with the FDA can be accurate, validated, up-to-date and trusted!
If you don’t have a single repository where all of your product master data can be managed, governed, version controlled and accessed, then you’re setting your company up for failure. Innovit’s GUDID.cloud solution enables you to overcome the technical challenges of submitting product data to the GUDID, while at the same time enabling you to gain incremental business value from your UDI investment. Innovit’s UDI solution is uniquely positioned to provide you with the training and support needed throughout the data gathering, maintenance and submission process, saving you time and money along the way. But most importantly, it ensures that you company avoids compliance penalties from the regulators, and ensure that products remain in the market to protect your revenue streams.
- Don’t be afraid to ask for help!
Innovit is here to help you on the path to regulatory compliance and we’re ready to help you prepare and meet the GUDID deadline of September 24, 2022 for risk Class I devices.
In fact, we have made it our New Year’s resolution to make YOUR data compliance simple!
With Innovit’s GUDID.cloud freemium plans, plus our comprehensive online knowledge base – the GUDID Reference Center – we have you covered!
Check out our GUDID Reference Center today – your one-stop website for UDI knowledge and everything you need to know about complying with GUDID submissions.
Get Started for free with Innovit’s GUDID.cloud system!