Compliance date extended for UDI label and data submission requirements to September 24, 2018, for certain class II devices.
Now that UDI Implementation has arrived, Medical Device Manufacturers and Labelers are scrambling to understand and meet the Compliance Timelines and requirements. The requests are pouring in for a verification solution to ensure the integrity of the symbol marking will accurately convey the information on your device through its lifecycle.
This extension does not apply to implantable, life-supporting or life sustaining devices.
Compliance dates for many Class ll devices will still follow the Compliance date schedule as below.
3 years after publication of the final rule (September 24, 2016)
What devices are considered exceptions:
- Collections of two or more different devices packaged together in which the devices in the package are not individually labeled. On January 4, 2016, the FDA issued a draft guidance document entitled “Unique Device Identification: Convenience Kits: Draft Guidance for Industry and Food and Drug Administration in which the agency proposes an interpretation of the term “convenience kit” for purposes of applying the exception under 21 CFR 801.30(a)(11). To allow FDA the ability to finalize this draft guidance document and the interpretation of what constitutes a convenience kit, the Agency is extending the compliance date for UDI label and GUDID submission requirements for collections of two or more different class II (or class II and class I) devices packaged together in which each device in the package is not individually labeled with a UDI to September 24, 2018. This extension does not apply to collections of devices that include one or more devices that are implantable, life-sustaining or life-supporting. Some labelers may have already implemented the UDI label requirements for these devices. In such cases, this extension would apply only to the GUDID submission requirement. The draft guidance document is intended to outline the agency’s proposed thinking that “convenience kit”, as defined by 21 CFR 801.3, applies solely to two or more different medical devices packaged together for the convenience of the user where they are intended to remain packaged together and not replaced, substituted, repackaged, sterilized, or otherwise processed or modified before the devices are used by an end user. This position would constitute a change in policy. Draft Guidance can be found at: http://www.fda.gov/downloads/MedicalDevices/DeviceRegulationandGuidance/GuidanceDocuments/UCM479242.pdf This draft guidance, when finalized, will represent the current thinking of the Food and Drug Administration (FDA or Agency) on this topic. It does not establish any rights for any person and is not binding on FDA or the public. You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations. To discuss an alternative approach, contact the FDA staff or Office responsible for this guidance as listed on the title page.
- Repackaged single-use devices
21 CFR 801.30(a)(3) provides that individual single-use devices, other than implants, all of a single version or model, are not required to bear a UDI provided they are distributed together in a single device package, intended to be stored in that device package until removed for use, and not intended for individual commercial distribution. The UDI label and GUDID submission requirements’ compliance dates for repackagers’ of class II single-use devices that are not individually labeled with a UDI is extended to September 24, 2018. This extension does not apply to implantable, life-supporting or life sustaining devices.
Compliance date for device constituents of certain 21 CFR 3.2(e)(2) and 21 CFR 3.2(e)(3) combination products assigned to CDER or CBER for premarket review and regulation is September 24, 2018
For device constituents, other than devices that are implantable, life-sustaining or life-supporting, of 21 CFR 3.2(e)(2)) (commonly referred to as “co-packaged”) and 21 CFR 3.2(e)(3) (commonly referred to as “cross-labeled”) combination products assigned to Center for Drug Evaluation and Research (CDER) or Center for Biologics Evaluation and Research (CBER) for premarket review and regulation, the compliance date for UDI label and GUDID submission requirements is September 24, 2018.
Realize the Importance of a Label on your device
A label is typically the only identifier of your device on the packaging
Much like a can of food from your pantry without a label, without the label, we do not know the contents, ingredients, or manufacturer.
Important Timelines to keep in mind.
GUDID data submitted to FDA and the UDI included on the label:
- Class III – 24th-September-2014
- Implantable, Life- Supporting ad Life sustaining Devices- 24th-September-2015
- Class II – 24th-September-2016
- Class I- 24th-September- 2018
- For a Complete Timeline Visit: http://www.fda.gov/MedicalDevices/DeviceRegulationandGuidance/UniqueDeviceIdentification/CompliancedatesforUDIRequirements/default.htm
Along with Implementation and assisting our Customers, we have defined several pain points that can be addressed and provide a bit more ease and assurance for Manufacturers and Labelers.
Understand the requirements and timeline for your Medical device class.
If you are uncertain of the classification of your device, visit the FDA’s classification database, where you will be allowed to search by Device name or Device panel (Medical Specialty) to which your device belongs. This database includes:
- a list of all medical devices with their associated classifications, product codes, FDA premarket review organizations, and other regulatory information
Labeling standards requirements for every manufacturer and device class can vary across product lines, manufacturers’ sites and business units including, but not limited to format, content, and data.
Previous labeling processes may not be compliant to the new guidelines, so verify and ensure your labels to avoid Production waste, and Costly Compliance errors found during your manufacturing process that may result in fines and legal action if mislabeled product is released to the market.
Remember, if you verify the symbol and then re-size the symbol prior to applying a permanent mark, verifying the symbol after all adjustments is also recommended, as well as verification of the first piece of marked product.
What is UDI?
UDI is a unique numeric or alphanumeric code assigned to a unique device. A UDI code consists of two parts:
- Device Identifier (DI) – a mandatory, fixed portion that identifies the labeler and the specific version or model of a device.
- Production Identifier (PI) –
a conditional, variable
portion of a UDI.
Each UDI must be provided in a plain-text form (readable to humans) and in a form that can be interpreted by automatic identification and data capture (AIDC) technology (readable to machines) on labels,
- Barcode readers
- Machine vision cameras
How do I obtain a DI?
Must be issued by an FDA-accredited Issuing Agency such as:
- Health Industry Business Communications Council (HIBCC)
- ICCBBA or ISBT 128
Once you select an issuing agency, you must know the specifications required for the issuing agency for you device and application. Including allowed symbologies for you to use as well as proper encoding of the data structure.
Be sure you know the approved data carriers (barcode types) for your agency’s standards and properly enter the data in the format as it is specified by the agency’s standards.
How will I know if my barcode symbol is compliant?
Barcode readers or scanners cannot be used for verification or Validation of your encoded data.
While the label may scan, a scanner or reader will only report what is seen.
A Scanner or a reader will:
- Recognize the barcode symbology
- Analyzes the content of the barcode
that is scanned
- Transmits the data to the computer in
a traditional format
What is Verification?
- Verification is an objective, well-documented measurement of the quality of a barcode symbol. It is a predictor of how well a code will be able to be read throughout its lifecycle.
- Verification is a method of analyzing a code against a published specification to determine whether the barcode is compliant to specifications (IN-SPEC) and will scan properly
- Microscan® verifiers ensure compliance and can also determine defects in codes that may affect readability.
Without verification, bad barcodes are not identified until they are unreadable. By the time a bad barcode is identified, several poor-quality barcodes may have already escaped down the line.
With verification, bad barcodes are prevented from being applied to the product, eliminating the chance for future failures.
The advantages of Verification:
- IN-SPEC” barcodes scan on the first attempt every time allowing end users to take full advantage of their scanning investment
- Lower costs
- Higher productivity
- 100% traceability
- Fewer errors
- Avoid customer fees
- Avoid rejects
- Limit returns and scrap
What are the Risks of Not Verifying?
- LOST OR MISINTERPRETED INFORMATION
- INCREASED LABOR COST
- HIGH DOLLAR RE-LABELING COSTS
- INCREASED ERRORS
- PRODUCT RECALLS
- REJECTED SHIPMENTS
- USER DISSATISFACTION
- RETAIL VENDOR COMPLIANCE PENALTIES
What is Validation?
Validation is the process of checking that the proper data has been encoded within a barcode. As an example, is data in the correct format? Is it Compliant to me Selected Issuing Agency Specifications? With the Microscan® line of LVS 95xx Verification systems, the encoded data is displayed as below so that you can confirm that the data is encoded as the labeler intended.
What if the encoded data is not compliant?
The Microscan® line of LVS 95xx Verification systems offers a vast selection of industry standards that you may select from based on your requirements and industry.
If your Application Standard is selected in the software EX: GS1 General Specifications or HIBC, the barcode will be graded for ISO/IEC 15415/15416 print quality parameters, but now will also validate that the data is encoded properly by following the specifications of your selected Application standard. If the Encoded data is not Compliant to the application Standard that you have selected, the barcode will fail and highlight the error in RED on the data structure analysis.
Pain Points that have been noted and that we can assist you with are:
Proper encoding of FNC1 and Application Identifiers in the GS1 General Specifications barcodes.
Formatting of encoded data Ex: Variable data strings requiring a stop character.
Why exporting and artwork variations of the symbol from the barcode generating software can affect quality.
Contrast with symbols, use best practices and aim for the highest achievable contrast.
At which processes verification and validation can be performed to assist you in maintaining a High Quality symbol.
Understanding the devices that require Direct Part Marking of the UDI.
What portion of the UDI is required to be submitted to the GUDID database and what part of the UDI is to be maintained by the manufacturer?
Once data is verified as the data intended by the labeler, maintain your quality to ensure that the symbol integrity is not compromised.
Defects that are defined in my symbols, how can I know the cause and possible solution for low symbol quality or encoded data errors?
Microscan® offers many support areas that can assist such as:
- Barcode Verification and analysis provided by Verfication experts.
- Training provided by certified GS1 Standards professionals.
- GS1 compliant Verification systems.
For more information, visit www.microscan .com