On June 23, 2015, the U.S. Food and Drug Administration (FDA) published a draft guidance regarding the placement of unique device identifiers (UDIs) directly onto devices. Most devices will soon be required to bear a UDI on their labels and packaging. For a device that is intended to be used more than once and intended to be reprocessed before each use, the UDI will also need to be permanently affixed to the device itself. This is called direct marking.
FDA considers “intended to be used more than once” to mean “intended for repeated uses on or by different patients.” Devices that are intended for multiple uses on the same patient do not need to comply with direct marking requirements. FDA defines “reprocessing” as “validated processes used to render a medical device, which has been previously used or contaminated, fit for a subsequent use.” For direct marking purposes, FDA only considers a device as “intended to be reprocessed” if it is intended to be cleaned and either disinfected or sterilized between uses. A device that is intended only to be cleaned between uses does not qualify.
How to Directly Mark a Device
The entire UDI must be directly marked on a device. During a January 2015 UDI and GUDID Webinar, FDA clarified that only the UDI must be placed directly on the device, not the device’s entire label. UDIs on labels and packaging must be displayed in both human-readable and machine-readable format. However, directly marked UDIs may be displayed in only one of the two formats. A directly marked UDI does not have to be the same as the UDI on the device’s label and packaging.
FDA does not have a specific method that labelers must use to mark a device. It is up to the labeler to determine an appropriate method. The labeler should consider the device’s expected usage and reprocessing, as FDA expects directly marked UDIs to last throughout the expected use life of the device. Some examples of marking methods offered in the guidance include:
- Attaching a permanent plaque to durable equipment
- Affixing a permanent tag to the device
Exceptions to Direct Marking Requirements
A device is exempt from direct marking requirements if:
- Direct marking would interfere with the safety or effectiveness of the device;
- Direct marking of the device is not technologically feasible;
- The device is a single-use device and is subjected to additional processing and manufacturing for the purpose of an additional single use; or
- The device has been previously marked under 21 CFR 801.45(a)
If a company decides to make use of a direct marking exception, the company should document its rationale and evidence for doing so within the device’s design history file. When submitting information to GUDID, the labeler should check the box for “Device Subject to Direct Marking (DM), but Exempt”.
Direct Marking Effects on 510(k), PMA, and BLA
If direct marking does not affect the safety and effectiveness of a device, then a new 510(k) submission or a supplemental PMA or BLA should not be necessary. The change should instead be reported in an annual report. As mentioned above, if direct marking does affect the safety and effectiveness of a device, the device may be exempt from direct marking requirements. If the company still wishes to directly mark the device, then a new 510(k) submission or a supplemental PMA or BLA will generally be required. In this case, the company must pay the applicable user fees.
Compliance Dates for Direct Marking Requirements
In some cases, the compliance dates for direct marking requirements differ from the compliance dates for including UDIs on labels and packaging. See the compliance date chart below:
Registrar Corp helps medical device companies comply with FDA UDI requirements. Registrar Corp Regulatory Specialists can assist you in determining the UDI requirements applicable to a particular device and can submit information to GUDID on behalf of your company. Registrar Corp also assists with other FDA medical device regulations, such as FDA registration and device labeling.
For questions about or assistance with UDI requirements or other FDA regulations for medical devices, contact Registrar Corp at +1-757-224-0177 or chat with a Regulatory Advisor 24-hours a day at www.registrarcorp.com/livehelp.