We’ve previously kept you informed on how to determine whether your product is regulated as medical device by the U.S. Food and Drug Administration (FDA) and how to register your medical devices with the Agency. On June 2, 2017, FDA issued a letter to Device Labelers of certain classes informing of extended compliance dates for UDI requirements. Today we are providing more information on medical device labeling requirements – specifically the new Unique Device Identification (UDI) requirement.
On September 24, 2013, FDA released a final rule establishing a unique device identification system “designed to adequately identify devices through distribution and use.” 78 FR 58786. The final rule established label and data submission.
The UDI Rule requires device labelers to include a UDI on EVERY device label and package, except where the rule provides for an exception or alternative. 21 CFR §801.20. FDA provided these exceptions and alternatives to ensure that the “costs and burdens on industry members are kept minimal.” The rule lists general exceptions and outlines the procedure for requesting a specific exception or alternative.
Notably, once the UDI Rule is fully implemented (see compliance dated below), the label of most devices will include a unique device identifier (UDI) in both easily readable plain-text and machine-readable form. The UDI will be required to be a permanent marking on the device itself if the device is intended to be used more than once and intended to be reprocessed before each use. 21 CFR §801.45. The final rule requires a single device identifier to be used to identify only one version or model of such device – the FDA rule prohibits device labelers from reassigning a device identifier to another device. 21 CFR §830.40(a) Only if a discontinued version or model is re-introduced and no changes have been made, the device identifier that was previously in use may be used to identify the device. See 21 CFR §830.40(c).
Data Submission Requirements
Additionally, Device labelers must also submit certain information about each device to FDA’s Global Unique Device Identification Database (GUDID). 21 CFR §830.300. As of May 1, 2017, more than 4,000 device labelers had submitted 1.4 million records to GUDID (most of this information is available to the public).
What is a Unique Device Identification (UDI)?
Pursuant to 21 CFR §801.3, A UDI is a unique numeric or alphanumeric code that consists of a (1) device identifier and (2) production identifier.
- A device identifier (DI), a mandatory, fixed portion of a UDI that identifies the labeler and the specific version or model of a device (see 21 CFR 801.3), and
- A production identifier (PI), a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of a device:
- the lot or batch number within which a device was manufactured;
- the serial number of a specific device;
- the expiration date of a specific device;
- the date a specific device was manufactured; or/and
- the distinct identification code required by §1271.290(c) for a human cell, tissue, or cellular and tissue-based product (HCT/P) regulated as a device.
FDA Sample Label
The UDI system will go into effect in stages, over a period of seven years, to ensure a smooth implementation and to spread the costs and burdens of implementation over time, rather than having to be absorbed all at once. Compliance dates have been set as follows:
|Device||Label/GUDID/DATE Format||DIRECT MARK – When required|
|Class III (including class III LS/LS)
Devices licensed under the PHS Act
|September 24, 2014||Class III LS/LS devices must bear a permanent UDI by September 24, 2015
All other class III devices must bear a permanent UDI by September 24, 2016
|Implantable (class II, class I & unclassified)
|September 24, 2015||N/A|
|LS/LS (class II, class I & unclassified)
|September 24, 2015||September 24, 2015|
|Class II (other than I/LS/LS)
|September 24, 2016||September 24, 2018|
|Class I & unclassified (other than I/LS/LS)
|September 24, 2020||September 24, 2022|
How to Obtain an UDI?
There are very specific technical requirements for UDIs. These requirements are set forth in 21 CFR §830.20. The technicality of the Rule led FDA to mandate that UDIs must be issued under a system operated by an FDA-accredited issuing agency and conform to certain international standards incorporated by reference in the UDI Rule under 21 CFR §830.10. It is critical that the FDA-accredited issuing agencies’ systems for issuing UDIs align with the UDI labeling requirements to ensure labelers to confidently use the FDA-accredited issuing agency’s system to develop UDIs that are in compliance with the UDI labeling requirements under 21 CFR §801.
Why should you care?
According to FDA, UDI implementation will improve patient safety, modernize device post market surveillance, and facilitate medical device innovation. More importantly, AVOID LIABILITY – the device “labeler” (in most instances, the device manufacturer is the labeler) has the responsibility for complying with the UDI label, data submission, and records requirements. Furthermore, AVOID CBP and FDA DETENTIONS. Under 21 CFR §800.55, FDA is vested with the authority to detain your medical devices intended for human use that are believed to be adulterated or misbranded. If FDA orders detention of your medical device, such “products may not be used, moved, altered, or tampered with in any manner by any person during the detention period. . .until FDA terminates the detention order or the detention period expires, whichever occurs first.”
How may DTL help?
We’ve given you the tools to determine whether or not your product is in fact a medical device, and a general understanding of FDA’s regulation of medical devices. For the purposes of UDI compliance, we are able to assess whether you qualify for a general exception or request a specific exception or alternative on your behalf. Should you not qualify for an exception, we may assist in assessing which data must be submitted to GUDID or alternatively obtain a waiver to avoid data requirements under the UDI Rule. For help contact us at firstname.lastname@example.org or 305-456-3830.
Additional Resources for Importing Medical Device:
“TOP TIPS WHEN IMPORTING MEDICAL DEVICES TO ENSURE COMPLIANCE”