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What is the GUDID?

This blog, “What is the GUDID?” reviews the basics of the database, do we need a GUDID account?, how data is submitted, what information is needed and more. 

What is the GUDID?

FDA, in creating the Unique Device Identifier (UDI), was looking to improve the postmarket surveillance process, which included developing a database, to be used by the healthcare community and the public to obtain critical information on the medical devices they use. The Global UDI Database (GUDID – pronounced Good-I-D) is a repository for key device identification information. It will not include any patient information. This key information – 62 different data elements (see below) – is limited to Device Identifiers (DI) and Labeler information. Every Labeler of medical devices is required to have a UDI and submit this information to the GUDID.

Changes from the proposed rule impacting GUDID

In the proposed rule, FDA did not want to use Global Medical Device Nomenclature (GMDN) Preferred Term (PT) codes. Unfortunately, the GMDN PT codes are not free and a subscription is required to access the GMDN database. FDA was able to negotiate an agreement with the GMDN Agency to allow Labelers access to the GMDN PT codes. These codes will only be accessible to Labelers who enter device information using FDA’s Web Interface submission process. A word of caution; the GMDN Agency is continually adding and updating these codes. Companies submitting data via HL7 SPL (see below) will need to subscribe to the GMDN Agency in order to gain access to these codes.

what is GUDID What is the GUDID?

Another change deals with MRI compatibility. If you claim your device is MR Safe, MR Conditional or MR Unsafe, then this information is now required as part of the submission to GUDID.

A new version of the GUDID Implementation Specification (Version 1.2.1, released April 11, 2014) is now available. FDA Global UDI Database Web Site 

Do we need a GUDID account?

In order to submit medical device key information, Labelers need to request an account through the FDA GUDID website. The Labeler Organization may have more than one GUDID account. A Duns and Bradstreet (DUNS) number for the company location is used to identify each GUDID account.

There are three (3) levels – Organization (which may also be a Labeler), Labeler and Third-Party (entity authorized to submit GUDID information on behalf of Labeler). Each GUDID account must have:

  • One (1) Regulatory Contact
  • One (1) Coordinator (manages Labeler Data Entry users)
  • One (1) Labeler Data Entry user (day-to-day data entry)
  • One (1) Labeler DUNS number

Labeler DUNS number must match name and address on the device label.

Production Identifiers (PI) are not entered in to the Database (just PI flags to indicate which PI are on the label). 

How data is submitted to GUDID

There are two standard-based methods to submit data: 1) structured input via a web interface, and 2) the Health Level 7 Structured Product Labeling (HL7 SPL) process. The first method, using a web-based interface, will work well for up to 200 total records. If you attempt to input more than 200 records the input becomes overwhelming and you will need to use the HL7 SPL process. HL7 SPL is in XML format and uses the FDA Electronic Submission Gateway (ESG) as the pathway to upload data into GUDID. Both submission methods are one DI record at a time. There is no batch option available.

You are also able to use third-parties to submit data. GS1 GDSN (Global Data Synchronization Network) is one example; there are others as well. Or you could build your own submission tool.

There are three (3) states of entry –

  • Draft DI – only available via Web interface (Draft DI will be available for 180 days)
  • Unpublished – has passed all the business rules
  • Published – is now searchable

Currently, the GUDID search and retrieval options are not currently operational, as FDA is waiting until sufficient data has been entered to turn this feature on.

What information do I need?

There are 60-plus data attributes that need to be provided. Some of the fields are automatically filled in by the GUDID system, based on information that is entered. For instance, the Labeler Name and Address are pulled from the DUNS database, based on the DUNS number entered. An entry can have more than one Device Identifier. This is usually the case if you have used different Issuing Agencies. Attributes on label/package and the values submitted should match. GUDID also has controlled vocabulary and built-in business rules that will continually check what data is input.

Controlled vocabulary are DUNS #, GMDN code and FDA Product Codes. 

Examples of Business Rules are:

  • All required data elements must be provided
  • Validating specific elements – FDA Listing #, etc.
  • Data constraints on specified elements – Publish date must always be >= TODAY
  • There are other additional business rules

Also, a DI can never be reused, even if it is discontinued. It will remain in GUDID, but marked as “Not in Commercial Distribution.”

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6 UDI Implementation Deadlines You Need to Remember

The first of the UDI implementation deadlines for the FDA’s Unique Device Identifier (UDI) Regulation is approaching fast. Do you know when your medical devices must be labeled with a UDI?  Read on to find out.

Screen Shot 2014 04 29 at 7.25.40 PM 6 UDI Implementation Deadlines You Need to Remember

FDA requires higher risk devices be brought into compliance with the UDI regulations first. Compliance starts with Class III devices and devices licensed under the Public Health Service (PHS) Act (http://bit.ly/PHS-Act).  Lower risk devices will follow.

1. June 23, 2014 is the compliance deadline for Class III and PHS Act device labelers to file a one-year extension. FDA requires extension requests be written (§801.55), documenting the number of labelers and devices subject to the request and explaining why an extension would be in the best interest of public health. FDA may also request additional information to help the Agency make a decision on this request. Federal Register – Class III Compliance Dates

2. September 24, 2014 is the first compliance deadline for labels and packages of Class III devices, Class III Stand-alone Software and devices licensed under the PHS Act to be “compliant.”  These devices must have a UDI on its packages and labels, human readable dates must be formatted as YYYY-MM-DD (§801.18) and information submitted to the Global UDI Database (GUDID) (§830.300) by this date.

3. September 24, 2015 is the compliance deadline required for labels and packages of Implantable, Life Sustaining and Life Supporting Devices to have a UDI and corresponding data submitted to GUDID.  Life Sustaining and Life-Supporting devices are also required to have UDI as a permanent direct mark if they are to be used more than once, and reprocessed before each use (§801.45). Stand-alone software that is life-sustaining or life-supporting must have a UDI per §801.50(b). Human readable dates on these labels must be formatted as YYYY-MM-DD.

4. September 24, 2016 is the compliance deadline required for Class II devices and Class II Stand-alone Software to be compliant. As with the device classes above, this means having the UDI on the device label and package (human readable date in YYYY-MM-DD format) and data submitted to GUDID.  Class III devices intended to be used more than once and reprocessed between uses must have their UDI permanently marked on the device by this date.

5. September 24, 2018 is the compliance deadline for Class I devices and Class I Stand-alone Software, as well as devices not classified into Class I, Class II or Class III. This date requires devices to have a UDI on their labels and packages, and the human readable dates on labels must be in YYYY-MM-DD format. Class II devices intended to be used more than once and reprocessed between uses must be direct marked with their UDI.

6. September 24, 2020 is the compliance deadline for Class I devices, and devices that have not been classified as Class I, II or III intended to be used more than once and reprocessed between uses, must be direct marked with their UDI.

FDA’s UDI final rule will be phased in over time to ensure that labelers would have adequate time to build and test systems, and create the infrastructure needed to implement the regulation’s many requirements. FDA believes a phased approach will spread the cost and burden of implementation over a number of years.  This approach, according to FDA, should promote “the efficient and effective implementation of the final rule.”

On-hand inventory labeled and packaged prior to the above deadlines has been extended a 3-year grace period in the Final Rule.  This inventory does not need to be relabeled/repackaged with their UDI until three (3) years past the compliance date of their product Class compliance date. FDA considers consignment inventory to fall under this provision. This requires companies to  track consignment inventory; ensuring it is used prior to the three-year grace period expiring. Any inventory – on-hand or consignment – remaining past the grace period will need to be relabeled and/or repackaged to be compliant. Federal Register – Existing Inventory

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What is UDI and Why It Matters

udi 2 300x162 What is UDI and Why It MattersIn this blog, “What is UDI and Why It Matters” the author reviews the fundamentals of UDI, FDA’s Final Rule applications and its global significance. 

FDA’s Final Rule (Federal Register – UDI Definition) states a Unique Device Identifier (UDI) is a code that sufficiently identifies a medical device throughout its distribution and use. The UDI is comprised of a static component, “Device Identifier” (DI) and a dynamic component, “Production Identifier” (PI). 

The DI itself is made up of your Labeler Identification Code and a code that pinpoints the specific version or model of that device. PI, on the other hand, includes manufacturing information for that specific device, such as lot or batch number, serial number, expiration date or manufacturing date (both in YYYY-MM-DD format).

Human cells, tissues, or cellular or tissue-based product (HCT/P) regulated as a medical device requires the use of the ISBT-128 format UDI. The UDI Final rule requires medical device labels to contain a UDI, unless exempt, or provides for an exception or alternative placement. The UDI must be both human readable and in a form that uses automatic identification and data capture (AIDC) technology. 

Reprocessed and Single-Use Devices

Medical devices that are both used more than once by intention and reprocessed by intention, must have the UDI directly marked on the device. The Final Rule details exceptions to this requirement (Federal Register – Direct Marking Requirement). UDI does not need to be on individual single-use devices. Instead, it needs to be located on the next higher package. For example, non-sterile exam gloves would require a UDI on the box label, not each glove. 

This section of the rule stipulates individual single-use devices, all of which are the same version or model, must be distributed together in a single device package; is intended to be stored in that device packaging until removed for use, and is not intended for individual sale.  However, it does not apply to implanted devices, which require a UDI on the package of the individual device. Federal Register – Single-use Device 

Stand-Alone Software

Stand-Alone Software that is regulated as a medical device must also bear a UDI. The software version should be included in the production identifier. If software is downloaded from a website, the UDI must be in plain text (i.e., not in AIDC format) and displayed whenever the software is stated and/or in plain text displayed through a menu command, such as the “About” screen. If Stand-Alone Software is sold in a package; the package must have the UDI on its label. However, the DI of packaged software may be identical to the downloaded version. Federal Register – Stand-Alone Software

Why Now? Why Does It Matter?

Some medical device companies, especially distributors, obscure manufacturers’ names and item codes on device labels. Different devices might have the same item code, while the same device might have different item codes. These inconsistencies confuse healthcare professionals—especially during recalls and adverse event reporting. Therefore, FDA and other regulatory agencies are implementing UDI regulations in order to:

  • Improve patient safety by reducing medical errors.
  • Strengthen the Electronic Medical Records initiative by providing a standard method for recording the identity of each device during use in clinical information systems, claim data sources and registries.
  • Address counterfeiting and diversion
  • Prepare for medical emergencies and disasters
  • Provide a foundation for a global, secure, distribution chain. 

The most important reason for UDI regulations is the need to improve the accuracy and timeliness of Post-Market Surveillance (PMS) data. More accurate and timely PMS data will indirectly improve patient safety by helping facilitate more accurate reporting, reviewing and analyzing of adverse event reports, so problem devices can be pinpointed, corrected and removed faster. 

Impact of UDI Regulations Globally

FDA hopes the UDI regulations will lead to the development of a globally harmonized medical device identification system that is recognized around the world. The European Union and regulatory agencies around the world are drafting their versions of a UDI regulation. In addition to the benefits of implementing a UDI system in general, a global UDI system would:

  • Allow companies to create globally harmonized labeling with a single UDI worldwide
  • Promote worldwide tracking and tracing of devices for easier recalls
  • Provide another risk control to prevent counterfeiting and diversion of medical devices

To that extent, the International Medical Device Regulators Forum (IMDRF) published their UDI Guidance document IMDRF UDI Guidance Document which has many similarities to the FDA Final Rule.

The Unique Device Identifier Final Rule is more than just a new FDA regulation—it is also good business practice. Healthcare customers are embracing the use of unique identifiers, and in past experiences with implementing GTINs (another form of UDI from the UDI issuing agency GS1) customers demanded implementation of GTINs, or they would find a new supplier. Manufacturers may choose to ignore one or two customers, but eventually the number of customers demanding UDI will be significant, and they will need to act quickly—regardless of FDA deadlines.

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Unique Device Identifier Final Rule-FAQs-Part II

Screen Shot 2014 04 03 at 10.24.33 PM Unique Device Identifier Final Rule FAQs Part II

Did you know that September 24, 2014 is the first UDI DEADLINE for Class III devices, Stand-Alone Software, and devices licensed under the PHS Act? 

Who is an Issuing Agency?

FDA has accredited three (3) agencies for the operation of a system to issue unique device identifiers.They are GS1 (www.gs1.org), Health Industry Business Communications Council (HIBCC) (www.hibcc.org) and International Council for Commonality in Blood Bank Automation (ICCBBA) (www.iccbba.org).  GS1 and HIBCC are for medical devices, while ICCBBA is for medical products of human origin that are regulated as medical devices.

We sell single-use devices; do we need to label these products?

A UDI does not need to be placed on each single-use device (i.e., primary packaging). Instead, the UDI is to be placed on the secondary packaging (e.g., outer box). For example, exam gloves. The UDI label goes on the box, not each glove. This rule requires the package:

  • Have a single version or model
  • Be distributed together in a single device package
  • Are intended to stored in that device packaging, and
  • Are not intended for individual sale

Placement of the UDI on the secondary packaging for single-use devices does not apply to implanted devices. While implants are technically “single-use” devices, implants (defined as devices placed in the body for 30 days or longer) must have a UDI on the primary packaging.  Federal Register – Singe-use Devices

I understand there are implementation deadlines; what are they?

There are several deadlines related to this new regulation based on device Class. For example, Class III devices, Stand-Alone Software, and devices licensed under the PHS Act must be “compliant” and have a UDI on its package label, and information submitted to the Global UDI Database (GUDID) by September 24, 2014. There is an opportunity to file for a 1-year extension for these classes of devices under §801.55. The deadline for filing this extension is June 23, 2014.

Other implementation deadlines are (includes submitting data to GUDID):

September 24, 2015            Implantable, Life Sustaining & Life Supporting Devices

September 24, 2016            Class II devices and Stand-Alone Software

Class III devices intended to be used more than once and reprocessed between uses must be direct marked with UDI

September 24, 2018            Class I devices and Stand-Alone Software

Devices not classified into Class I, II or III

Class II devices intended to be used more than once and reprocessed between uses must be direct marked with UDI

September 24, 2020            Class I devices, and devices that have not been classified as Class I, II or III, intended to be used more than once, and reprocessed between uses, must be direct marked with UDI

On-hand inventory labeled prior to the deadline, does not need to be relabeled with a UDI for up to three (3) years past the deadline. FDA considers consignment inventory to fall under this rule. This requires that you track consignment inventory, as well as ensure the inventory is used prior to this three-year exception expiring. Federal Register – Implementation Dates

Our device is packaged one unit per package; do we need to label the device itself?

This is a “unit of use” issue. If you sell 10 individually packaged devices ONLY in an outer pack, the individual devices do not require a UDI. Generally, labeling the outer pack with the UDI is sufficient. This assumes the device is stored and used that way.

I heard information on our devices needs to be submitted to a “database.” Please explain?

UDI has been implemented to facilitate postmarket surveillance activities, including the identification of medical devices through their distribution and use. FDA believed a significant part of this was the ability for healthcare professionals and users to “search” a database to locate information about devices. This resulted in the creation of the Global Unique Device Identification Database (GUDID) system, which is a repository for 60-plus attributes for each Device Identifier and its corresponding Labeler information.  Federal Register – GUDID Information

How do we submit data to the Global UDI Database?

There are two standard-based methods to submit date to the Global UDI Database (GUDID) – structured input via a FDA web interface, or using the Health Level 7 Structured Product Labeling (HL7 SPL) process. HL7 SPL is in XML format and uses the FDA electronic submission gateway as the pathway to input data into GUDID. In order to submit data to GUDID, you first need to request a GUDID user account from FDA. Data is submitted one record at a time for both methods. There is no batch process.  Federal Register – GUDID Submission

What additional information needs to be printed on a label under this new rule?

Medical devices must also follow labeling requirements detailed in Title 21, Subchapter H, §801, in addition to the new requirements per the UDI rule. Required information printed on the labels is also dictated by other regulatory agencies, such as the EU. Specifically, the UDI regulation requires a UDI be printed in easy-to-read plain text, and in an Automatic Identification and Data Capture (AIDC) format and placed on the device label. The AIDC format is dictated by the format of the issuing agency you have chosen. The other label element FDA requires is the date format when a date is used on a label. The date format is YYYY-MM-DD, and a day must always be used.  Federal Register – UDI Format

When do I need a new Device Identifier?

A new UDI is required when there is a change to a version or model. If you are calling the device a new version or model, and the users think the same, then it is a new device and requires a new Device Identifier (DI) and label changes. If the number of units in a device package changes – for instance, going from 5 to 10, then a new DI is required. This aspect often confuses people, as they think it has to do with changes in package artwork.  Federal Register – New UDIs

Need More Information on how to design and implement a compliance plan for the Unique Device Identifier Rule? 

FDA UDI Regulation on Medical Device Labelers is a complimentary webinar and powerpoint training presented by subject matter expert, Jon Bretz. To access – CLICK HERE

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Unique Device Identifier Final Rule-FAQs-Part I

Screen Shot 2014 04 03 at 10.23.51 PM Unique Device Identifier Final Rule FAQs Part IThis blog, “Unique Device Identifier Final Rule-FAQs-Part 1,” answers questions, such as, what is a UDI? Who is responsible for applying the UDI label? etc. 

What is a “UDI?”

The Unique Device Identifier (UDI) adequately identifies a device throughout the supply chain and while in use. It is constructed of two main sections – a device identifier and production identifier. The device identifier is comprised of a permanently assigned product code (model or version) and a labeler identification code. The production identifier is a dynamic component and made up of a lot number, serial number, manufacturing date, expiration date, etc. The device identifier and production identifier together make up the UDI.  Federal Register – Unique Device Identifier definition

Who is responsible for applying the UDI label? 

FDA has defined the “Labeler” to be the entity responsible for applying the UDI label. This entity may or may not be the actual manufacturer. The Labeler is defined as the entity that causes a label to be secured to a device, and who places the device in to commercial distribution with the expectation the label will not be replaced or modified in any way. Additionally, should an entity replace or substantially modify the original label, and then place the device into commercial distribution with the expectation the label will not be replaced or modified in any way is also a Labeler. Distributors who simply add their name and address to the package are not defined as a Labeler under this definition. 

Private label devices present a situation where the actual manufacturer, or brand name holder can be the Labeler. This would be a business decision between the manufacturer and brand name holder. The Labeler may also be the specification developer, a single-use device reprocessor, a convenience kit assembler, a repackager, or a relabeler.  Federal Register – Labeler definition

What does “standardized” date format mean? 

FDA has decided for all human readable dates (manufacturing date, expiration date, etc.) printed on labels must follow an YYYY-MM-DD format. The DAY is an absolute requirement. For example, March 31, 2014 must be presented as 2014-03-31. This requirement applies to ALL medical device classes that use a date on their label. Federal Register – Date format definition

I have kits that are comprised of several devices; how does this rule apply to me?

There are many types of kits. Kits can be made up of one or more medical devices, packaged together with one or more combination products, drugs, or biologics, to expedite a single surgical or medical procedure. §801.30(a)(11) states when a device is packaged within the “immediate container of a combination product or convenience kit, the label of the device will not be required to bear a UDI,” as long as the label on the kit has a UDI. Should your kit have a National Drug Code (NDC) number on its label, it does not also need to have a UDI.  §801.30(b)(3) clearly states devices that are included in a combination product with an NDC number on its label, and does not have a UDI, the device components must bear a UDI on its label. Federal Register – Kits Exemption

What does reprocessing mean? 

FDA uses the term “reprocessing” in conjunction with direct marking of a unique device identifier. Devices intended to be used more than once must have the UDI permanently marked directly on the device (with a few exceptions), and will be reprocessed between each use. However, FDA has not yet defined what “reprocessing” means. I have asked FDA this question, with their response being they will “shortly” issue additional guidance on this matter. When they do, I will let you know via this blog. Until they do, use the following definition of “reprocessing” – clean, clean plus disinfected, or clean plus sterilized. Federal Register – Direct Marking and Device Reprocessing

We sell software that is considered a medical device; how do I label these devices?

Stand-Alone Software (SAS) regulated as a medical device must also have a UDI. SAS that is downloaded from the web and/or sold packaged must use the version number (as the lot number) in its production identifier. The full version of the UDI must be displayed in easy-to-read plain text, following the rules of the issuing agency you have selected, on the start-up screen and/or a menu command screen, such as the “About” screen. The UDI on the SAS packaged form may have the same device identifier. Federal Register – Stand-Alone Software

What is a device package? 

A device package is a package that contains a fixed number of a specific version or model of a device. The use of this term has often confused people who think it has something to do with the package design. Federal Register – Device Package definition

Do I need to label our shipping containers? 

A shipping container, for the purpose of this regulation, is defined as a container used to ship or transport devices in which the items within may change from one shipment to another. The rule does not require a UDI label for any shipping container. Federal Register – Shipping Container

The author, Jon Bretz (guest blogger), can be contacted at 617-356-7776, or jbretz@rsqmassociates.com

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