On September 24, 2013 the US FDA released a final rule requiring that medical devices distributed in the US carry a Unique Device Identifier (UDI) and that product information pertaining to the devices be submitted to the FDA's Global Device Identification Database (GUDID). This rule also requires direct part marking (DPM) on products that will be used more than once and intended to be reprocessed before each use. In addition to this ruling, a new standardized date format on all medical device labels will be required.
The following Frequently Asked Questions provide more detail about the UDI ruling and how Aesculap will comply:
What is UDI?
Unique device identifier (UDI) means an identifier that adequately identifies a device at the point of distribution and at the point of use. A unique device identifier is composed of:
A device identifier - a mandatory, fixed portion of a UDI that identifies the specific version or model of a device and the labeler of that device;
A production identifier - a conditional, variable portion of a UDI that identifies one or more of the following when included on the label of the device: The lot or batch within which a device was manufactured;
The serial number of a specific device;
The expiration date of a specific date;
The date a specific device was manufactured.
For an HCT /P regulated as a device, the distinct identification code required by 1271.290(c) of this chapter
What are the FDA UDI regulations?
The FDA website states, "FDA is establishing a unique device identification system to adequately identify medical devices through their distribution and use. When fully implemented, the label of most devices will include a unique device identifier (UDI) in human- and machine-readable form. Device labelers must also submit certain information about each device to FDA's Global Unique Device Identification Database (GUDID)." Read more
Who has to comply with the UDI regulations?
All medical device companies must comply with the UDI regulations.
What are the benefits of UDI?
According to the FDA website, "The unique device identification system, which will be phased in over several years, offers a number of benefits that will be more fully realized with the adoption and integration of UDIs into the health care delivery system. UDI implementation will improve patient-safety, modernize device postmarket surveillance, and facilitate medical device innovation."
Visit the "Benefits of a UDI system" page on the FDA website for more information.
How will Aesculap comply with UDI?
Aesculap distributes Class III, Class II and Class I products. Aesculap will be compliant with the UDI regulations within the timeframe required by FDA.
Where can I find UDI information on Aesculap packaging?
What is direct part marking?
Direct part marking helps to ensure the adequate identification of devices through their distribution and use. Direct part marking is required for all devices that are intended to be used more than once, and intended to be reprocessed before each use.
The UDI requirements require direct part marking, which means that in addition to the product label containing UDI information, the device must also bear a permanent marking providing the UDI information.
- Direct marking requirements do not apply to any device that meets any of the following criteria:
- Direct marking would interfere with the safety or effectiveness of the device
- Direct marking is not technologically feasible
- Device is a single-use device and is subjected to additional processing and manufacturing for the purpose of an additional single-use
- Device has been previously marked under 21 CFR 801.45(a)
Where can I find UDI information on an Aesculap product?
Aesculap will supply UDI information on the product label as well as a laser etched, machine-readable data matrix that contains the Global Trade Item Number (GTIN) and other required information for products required to be direct part marked.
Will product numbers for Aesculap change as UDI is implemented within the label?
No, Aesculap will continue to display catalog product numbers / model numbers on product labels.
What is the GUDID?
The GUDID is a publicly searchable database that contains the device identification (DI) portion of the UDI for every medical device as well as contains other required information. All medical device companies must submit DI information to the GUDID. Access the GUDID
What is GTIN?
The GTIN is the globally unique GS1 Identification Number used to identify "trade items." GTINs are assigned by the brand owner (labeler) of the product, and are used to identify products as they move through the global supply chain to the hospital or ultimate end user.
Who is the accrediting agency Aesculap will use for assigning GTINs?
Aesculap will be utilizing Global Standards 1 (GS1), which is accredited as an issuing agency for UDI by US FDA. They are a neutral, not for profit, international organization that develops and maintains standards for supply and demand chains across multiple industry sectors. They operate a system for assignment of UDIs according to the final ruling.
When a customer places an order with Aesculap will anything change as a result of the UDI?
Customers can continue to use Aesculap catalog product numbers to place orders and the invoice and packing slip will remain the same.
What is the timeline to comply with the UDI regulations?
|Device||Label/GUDID/Date Format||Direct Mark (When Required)3|
|Class III (including Class III LS/LS)1||September 24, 2014||Class III LS/LS devices must bear a permanent UDI by September 24, 2015|
|Devices licensed under the PHS Act||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/LS1 (Class II, Class I & unclassified)||September 24, 2015||September 24, 2015|
|Class II (other than I/LS/LS2)||September 24, 2016||September 24, 2018|
|Class I or unclassified (other than I/LS/LS2)*||September 24, 2020||September 24, 2022|
1 LS/LS = life-supporting or life-sustaining
2 I/LS/LS = implantable, life-supporting or life-sustaining
3 Direct Mark requirements apply to products that are intended to be used more than once and intended to be reprocessed before each use. Direct mark compliance dates are in addition to lable/GUDID/date format compliance dates.
*Note: FDA has established enforcement discretion for certain Class I and unclassified devices, which has extended the compliance dates for UDI labeling and direct part mark requirements.
If you have additional questions about how Aesculap is complying with the UDI regulations, please e-mail Aesculap Customer Service.