FDA’s GUDID Medical Device Data Corrections – Implications of the Shortened Grace Period
In 2014, the seven-day grace period for Global Unique Device Identification Database (GUDID) submission corrections was extended to 30 days. Over time, healthcare providers provided feedback stating that 30 days is too long to wait for access to “key information” that could impact patient outcomes.
This year, the FDA returned to its original 7-day grace period for time labelers to review, edit and correct submissions. The FDA also added a new feature to GUDID that allows Device Identification (DI) records to be unlocked for editing/correcting submission errors, after the grace period has ended.
Less Flexibility: The FDA states their expectation that “labelers have sufficient data quality controls in place to ensure that initially submitted GUDID data are complete and accurate.” So, the grace period for labelers begins the day after the DI record is submitted. Once the record is made public, the ability to edit becomes limited, so as not to confuse data users.
Submission changes that can be made after the 7-day grace period are very limited. It’s likely that labelers will workaround this limitation by allocating new device identifiers to the same device. And of course, that adds more time, money and complexity to the process. Worse still, when two (or more) DIs are assigned to products, the result can be delays in products reaching the market.
The bottom line is this: the FDA expects device labelers to have sufficient data quality controls in place to ensure that all master data submitted to the GUDID are complete, accurate and up-to-date. Make certain to establish a primary source of product data to ensure the information you share with the FDA is trusted and accurate.
Learn how to develop your sustainable processes for submitting product data successfully to the GUDID. Our solutions solve these challenges by allowing device manufacturers to implement a “global system and unified process” for submitting product data to all regulatory agencies around‑the‑world.