EAS reminds all medical device firms that the compliance date by which devices must have a UDI is approaching. For more details on this requirement we invite you to read an EAS authored article in MedTech Intelligence. Timely compliance will ensure that your products will not be considered misbranded.
Compliance Date Approaching for FDA Unique Device Identifiers
Amy Scanlin, M.S.
Published in MedTech Intelligence
FDA has been phasing in enforcement dates for UDIs with the next, September 24, 2020, as the date by which all “Class I devices, and devices that have not been classified into class I, class II, or class III that are required to be labeled with a UDI, must a bear UDI as a permanent marking on the device itself if the device is a device intended to be used more than once and intended to be reprocessed before each use. § 801.45.”1
Enforcement of UDI labeling (21 CFR 801.20 & 801.50), GUDID Data Submission (21 CFR 830.300), and Standard Date Format (21 CFR 801.18) requirements will begin September 24, 2021.
If you are a device labeler, or the company that applies the label to a device, or who causes the label of a device to be modified, with the intent that the device will be commercially distributed without any subsequent replacement or modification of the label, you must obtain a UDI and submit that information to GUDID no later than September 21, 2020 (with noted exceptions). In most instances, the labeler is the device manufacturer, but the labeler may be a specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.
Now is the time to begin thinking about the process of obtaining UDI numbers for your devices and getting those numbers registered with GUDID. If you are unsure whether you are considered a labeler in the eyes of FDA, or need assistance with understanding your UDI requirements or obtaining a UDI number and submitting to GUDID, contact a reputable consulting firm for assistance. If you are a foreign firm intending to export devices to the U.S. market, notify FDA of your U.S. Agent.
Accurate and timely compliance with FDA’s law ensures your products will not considered misbranded, leading to FDA enforcement actions.