FDA Answers Frequently Asked Questions (FAQs) for Unique Device Identifier System.
Section 226 of the Food and Drug Administration Amendments Act of 2007 (FDAAA, which is downloadable below after registration) and section 614 of the Food and Drug Administration Safety and Innovation Act of 2012 (FDASIA) amended the Federal Food, Drug, and Cosmetic Act to add section 519(f), which directs FDA to publish regulations establishing a unique device identification system for medical devices. On September 24, 2013, FDA published a final rule establishing a unique device identification system (the UDI Rule).
While some parts of the rule became effective on October 24, 2013 and some became effective on December 23, 2013, most requirements within the rule have later compliance dates, as will be explained in Section A.2. of this document.
In developing the UDI Rule, FDA solicited input from a variety of stakeholders (e.g., manufacturers, global regulatory bodies, the clinical community, patient advocates) to ensure that as many perspectives were incorporated as possible.
Here are some important questions & answers (representative) provided by the FDA’s guidance.
Question: What products are subject to the requirements of the UDI Rule?
All devices, as defined by 21 USC 321(h), are subject to the requirements of the UDI Rule, unless an exception or alternative has been granted.
By what date must a device be in compliance with UDI requirements?
Is there a standard format for dates on the device label?
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What is a device package?
For purposes of UDI label and GUDID submission requirements, a device package is a package that contains a fixed quantity of a particular version or model of a device. In order to adequately identify a device throughout distribution and use, the various package configurations, i.e. each different type of package, must have a unique identifier, 21 CFR 801.20(a)(2). Thus, if a device is sold in individual device packages boxes of thirty (30) devices, and in cartons that contain twelve (12) boxes of thirty (30) device packages, a different DI would be required to appear on the individual device package, on the box of thirty packages, and on the carton of twelve boxes of thirty device packages. See Section 22.214.171.124 of the Guidance titled “Global Unique Device Identification Database (GUDID)” issued on June 27, 2014, for more information.
Are single-use devices required to bear a UDI?
Generally, a single-use device is required to bear a UDI on its label. One general exception to that requirement is where individual single-use devices all of a single version or model are distributed together in a single device package and intended to be stored in that device package until removed for use. Then the UDI is not required on the device label, but is still required on the device package. This exception is not available for any implantable device. Also, if the devices are intended for individual commercial distribution, the device label and package for these individual devices is required to bear a UDI. 21 CFR 801.30(a)(3) Single use devices are not required to bear a permanent UDI, even if re-processed. 21 CFR 801.45(d)(3).
In what form should a UDI appear on a device label and on device packages?
21 CFR § 801.40(a) requires each UDI to be provided in a plain-text version and in a form that uses automatic identification and data capture (AIDC) technology. AIDC means any technology that conveys the unique device identifier or the device identifier of a device in a form that can be entered into an electronic patient record or other computer system via an automated process. Plain text consists of legible characters that can easily be read by people. No particular font or point size is specified for the UDI; rather, the UDI would be subject to existing requirements that govern medical device labels, including 21 CFR § 801.15, concerning prominence of required label statements.
What are the UDI conforming amendments?
The UDI final rule makes changes to certain parts of 21 CFR governing FDA’s existing regulatory systems and processes to integrate UDIs and device identifiers. These changes, known as the conforming amendments, affect part 803 (Medical Device Reporting), part 806 (Medical Devices; Reports of Corrections and Removals), part 814 (Premarket Approval of Medical Devices), part 820 (Quality System Regulation), part 821 (Medical Device Tracking Requirements), and part 822 (Postmarket Surveillance).
Where is the UDI to be placed?
The UDI is to be placed on the device label, device packages, and, if the device is intended to be used more than once and reprocessed between uses, on the device itself.
When does a device need to be directly marked with a UDI?
Devices intended to be used more than once and intended to be reprocessed before each use are required to bear a permanent UDI affixed to the device itself unless one of the 21 CFR §801.45(d) exceptions applies.
What are the 21 CFR §801.45(d) exceptions from direct marking requirements?
Direct marking exceptions apply to any device that meets any of the following four criteria:
- Any type of direct marking would interfere with the safety or effectiveness of the device;
- the device cannot be directly marked because it 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).
Register to download FDA guidance for FAQs, issued on August 20, 2014
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