Did you know? The FDA Class I deadline enforcement is occurring on December 8, 2022.
Many in the medical device industry make plans to use the free FDA Web Interface based on the assumption that they don’t have enough products to warrant the use of Structured Product Labeling (SPL) for their GUDID submissions. The decision would seem to make sense for a company with 100 or fewer UDI device records that may be able to slog through the manual effort of entering each one into the FDA’s Web Interface before the Class I deadline December 8, 2022.
Questions to ask about Class I Exceptions
Recent FDA guidance has identified Class I Exceptions for this year’s compliance activity. If you market your Class I device according to one or more of the following conditions, the Class I GUDID Submission Exception does NOT apply and you must report product data to the FDA GUDID.
- You distribute your Class I device to professional healthcare facilities (hospitals, clinics, physician offices, etc.)
- Your Class I device is intended only for use by healthcare professionals
- Your Class I device is reused on different patients and reprocessed using high-level disinfection and/or sterilization
- Your Class I device requires 510(k)
While it may seem like submitting in SPL format to the FDA’s UDI database holds few advantages for companies with smaller product portfolios—especially in the rush to achieve initial UDI compliance by the deadline—medical device labelers often overlook key considerations for long-term compliance, data accuracy and the true cost of a “free” GUDID submission solution:
1) Manual entry and management of UDI data is a time-intensive process susceptible to human error. Manual entry of all of the data fields required for each record is likely to result in typos and other data problems due to human error. Post-submission, keeping record of GUDID entries in spreadsheets is also problematic and an ongoing compliance risk. Data validation in the Web Interface is limited, as is the ability to easily edit entries after they are published.
2) Submission via the Web Interface demands significant personnel resources and expertise. Many of our customers with a comparatively small number of records to submit have told us that they simply cannot afford to dedicate the efforts of their regulatory staff to entering their UDI records and maintaining them through the Web Interface. They decided the real cost of choosing an experienced submissions partner was lower than that of choosing a “free” solution while paying the ongoing costs and assuming the risk of manual entry and maintenance.
3) UDI in the U.S. is just the beginning. There are UDI initiatives in various stages of development all over the world, including Europe. Any device labelers marketing products outside the U.S. should consider how their chosen solution will equip them to meet coming mandates around the world. Since the FDA’s Web Interface is designed to submit only to the FDA’s GUDID, labelers who choose not to submit in SPL would need to start the process from scratch for submissions to other regulatory authorities.
Not sure whether you have enough products to effectively leverage SPL submissions?
Contact us by email at [email protected] or phone (+1-215-557-3010) to learn about how SPL submissions to the GUDID and a flexible database solution can lower the long-term costs of UDI compliance and reduce the risk of inaccuracies.