March 10, 2023

FDA UDI for Class 1 510(k)-Exempt Devices

I recently received an inquiry about the UDI implications of a device that the Labeler had previously miscategorized.  FDA’s class-based UDI requirements are governed by the way FDA (i.e., the applicable U.S. classification regulation) categorizes/classifies the subject device; not by how the Labeler categorizes the subject device.  In other words, even if the Labeler had previously miscategorized its devices, then that doesn’t justify the Labeler not meeting the applicable UDI requirements.  In other words, FDA would still penalize (i.e., via Form FDA 483, Warning Letter, Untitled Letter, etc.) the Labeler for noncompliance with the UDI requirements even if the Labeler didn’t believe or understand that it was subject to those requirements.

Note that if the subject device is FDA Class I GMP-Exempt, then such a device is wholly exempt from UDI requirements, including the requirements to submit data to the GUDID.  In that case, the Class I device UDI compliance dates are moot.

If Class I but not GMP-exempt, then September 24, 2022 is the FDA enforcement discretion compliance date for the 801.18, 21 CFR 801.20, 21 CFR 801.50, and 21 CFR 830.300 requirements for those devices, rather than the original September 24, 2018 compliance date (as long as those devices are not implantable, life-supporting, or life-sustaining).

A three-year grace period ending September 24, 2021 (lengthened via FDA enforcement discretion to September 24, 2022) existed for Class I non-GMP-exempt devices manufactured and labeled before those devices’ original September 24, 2018 compliance date. But that three-year grace period was for existing inventories (i.e., inventories not yet sold, i.e.., existing unsold inventories of devices manufactured and labeled before those devices’ original September 24, 2018 compliance date); it doesn’t apply for devices already marketed.

So again ultimately, Class I devices that aren’t GMP-exempt and aren’t implantable, life-supporting, or life-sustaining, shall have complied with the 801.18, 21 CFR 801.20, 21 CFR 801.50, and 21 CFR 830.300 requirements by September 24, 2022.  In other words, if this category of devices were marketed on or after that date without conforming with these UDI requirements, then those devices are misbranded (i.e., they’re not in compliance with U.S. medical device labeling law).  That means the responsible party needs to figure out whether those misbranded units need to be recalled, or if they can instead remain in the marketplace.  That decision hinges on FDA’s recall trigger criteria; specifically, in whether it a level of misbranding against which FDA would initiate legal action, e.g., seizure, in order to maintain public health.

Also of note: Some UDI direct-marking requirements may have longer enforcement dates than those aforementioned, but that will require further discussion which seems to be outside the scope of our immediate question at the moment, so I’ll forego further attention to that for the time being.