The second phase of UDI compliance for Class II I/LS/LS medical devices has now been implemented, leaving Class II device manufacturers wondering how to best prepare for the device data submission deadline on September 24, 2016.
The FDA’s UDI mandate requires unique device identifiers (UDI) be included with labeling and packaging on all Class II medical devices and entered into the FDA’s Global Unique Device Identification Database (GUDID).
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With more stringent requirements and less time to submit data, it’s important for device manufacturers to dive into the details of this new compliance reality and start preparing now.
To help you through the preparation process, we’ve put together a list of prerequisites to consider as you prepare your Class II devices for compliance with the FDA’s UDI mandate.
1. Get your dates straight
Planning out your preparation ahead of time is key, but it’s important to note that a few of the device compliance deadline dates have changed since the FDA put out its final ruling.
Let’s start with the closest deadlines and explore the subsequent dates in order:
Medical Device Compliance Requirements on September 24, 2016:
- • Labels and packages of Class II medical devices must include a UDI
- • Any standalone software for Class II devices must give a UDI
- • Dates on packaging and labels must be correctly formatted
- • Data for Class II devices that require a UDI must be submitted to the GUDID
Note: In addition to Class II device requirements, Class III devices that require UDIs and are intended to be used more than once (or reprocessed) require a permanent marking on the device itself.
Medical Device Compliance Requirements on September 24, 2018:
Class II devices intended to be reused or reprocessed require a direct UDI marking
Medical Device Compliance Requirements on September 24, 2020:
- • Class I and unclassified devices intended to be reused or reprocessed require a direct UDI marking
2. Determine whether your devices will need to be directly marked with an UDI
In the simplest terms, if a device is going to be reprocessed or used more than once (and won’t be implanted) it must be directly marked with a UDI.
3. Receive Device Identifier number and agency membership
UDIs are made up of Device Identifiers (IDs)—numbers based on the version or model type of the device, and Product Identifiers (PIs) including the lot and serial number and/or expiration date.
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Define Identifiers are used as keys to access information about the specific device within the GUDID. The FDA has accredited three agencies—GS1, HIBCC and ICCBBA— to issue DIs for devices. Labelers are required to get a membership from one of these agencies to be issued a DI number for the GUDID.
4. Perform a compliance gap analysis
Don’t narrow your regulatory focus to just one area. Review all FDA requirements for your product and perform a gap analysis to identify potential lapses in data so issues can be fixed ahead of time.
Here are a few things that can be easily overlooked:
- • Getting complete DI or PI information
- • Organizing data from multiple sources
5. Submit your data to the GUDID
Submitting data to the GUDID depends on how many product portfolios you’re managing.
Typically, the fewer you have, the easier it is to use the FDA’s free GUDID web tool. If you choose to take this route, keep in mind that only one DI record can be submitted at a time.
If you have many portfolios, you may want to use the HL7 SPL option, which converts electronic data into a consolidated SPL format before submission to the FDA’s Electronic Submission Gateway.
6. Establish your GUDID account
Whether you manufacture or label medical devices, you’ll need at least one GUDID account. You may need more based on how many GUDID-related roles you wish to allocate.
Keep in mind that all roles that involve data entry into the GUDID require FDA approval before creating the account.
To create a GUDID account, send an email request to the FDA. You should receive an account request form to fill out and send back for review. If approved, you’ll be given GUDID account login information via email.
Implementing UDIs can be a complicated process that demands solid processes, attention to detail and planning. Click here to contact The FDA Group today to learn how our team of former FDA and industry experts can help you overcome these regulatory compliance challenges or grab our free whitepaper: New Regulations on Unique Device Identification.