Manufacturers who have already successfully completed the first two compliance rounds know that achieving compliance is not a straightforward task. This is all the more reason to be proactive and to approach UDI with a view to drawing out all the potential benefits it offers.
A Revision Lesson
By September 24, 2014, the FDA required labels and packages of Class III devices and stand-alone software to bear a UDI label, with data submitted to the Global Unique Device Identification Database (GUDID) by the same date. By September 24, 2015, the labels and packages of implantable, life-supporting, and life-sustaining devices and life-supporting or life-sustaining stand-alone software were required to have a UDI label, with data again submitted to the GUDID by the same date.
The next compliance date in September 2016 applies to Class II medical devices and stand-alone software. The remaining compliance dates—September 24, 2018 and 2020—apply to Class I devices and devices not classified as Class I, II, or III.
Convenience kits must bear a UDI, though devices packaged within the container of the kit are exempt. It should be noted that this could become complicated when kits contain both Class I and Class II devices, such as some orthodontic kits, especially when the manufacturer must disclose materials.
If a device is intended to be used more than once and reprocessed before each use, it will be separated from the device label and packaging. This is why UDI requires direct marking on these devices, with the exception of implantable, life-supporting, and life-sustaining devices. This marking must last throughout the device’s lifecycle; manufacturers must therefore decide on the safest and most sustainable marking method.
Put Your Thinking Cap On
Proactive manufacturers will be thinking about how to address challenges that may come up during the compliance process. There are five key areas that manufacturers should take a close look at before proceeding.
1. In Vitro Diagnostics (IVD) Devices
UDI will be an invaluable tool for spotting potential problems with IVD devices. However, when it comes to labeling, the FDA has yet to explain the right process. Using the example of blood diagnostic equipment, one manufacturer may register the machine as a whole unit, whereas another manufacturer may label each entity separately (e.g., the machine, a blood sample container, and software to analyze the blood).
2. Exempt Devices
Devices manufactured and labeled before their compliance dates are exempt from UDI labeling requirements for three years, though the data must be filed with the GUDID. The FDA may also grant exemptions in the following cases:
- The requirements don’t appear to be technically feasible
- The device is intended for research and educational purposes
- The device is a custom-made or investigational device
To ensure maximum protection of patients, high-risk devices that previously required a serial number will continue to do so with UDI. GUDID does not contain serial numbers for privacy reasons; the FDA requires that manufacturers maintain production identifier fields internally. Some data, such as previous device identifier, is required for GUDID submission but is not currently being collected by the FDA. Manufacturers should collect all the data required under the UDI Final Rule in case there are any future changes, or in case there is an audit.
The required information for GUDID submission includes:
- Company name
- Contact information
- Device count
- Model and/or catalog number
- Device description
- Commercial distribution status
- Quantity per package (if applicable)
- Device status (human cell or tissue, kit, or combination product)
- FDA listing number
The FDA’s priority is to safeguard patient safety and therefore, Class I devices, which pose a low risk to patient safety, are subject to less regulatory control by the FDA than Class III devices. The Centers for Medicare and Medicaid Services (CMS) looks at risk in terms of fraudulent claims, billing of counterfeit products, and related infractions.
Healthcare fraud has huge financial implications for the sector. Improved identification will make it much harder to manipulate the claims system. For instance, if CMS receives a claims form for a high-risk device, and is able to see the serial number for this device, it can immediately decide whether or not to make the payment. In the past, CMS would pay first and investigate later.
5. Post-Market Surveillance and the Recall Process
UDI should be included in procedures for complaints, medical device reporting (MDR), corrections, recalls, and service reports. The MDR initiative links to the public Manufacturers and User Facility Device Experience MDR database; however, it is important to note that UDI information in that database is usually redacted or not included.
Scoring Full Marks
Initial UDI implementation will be a learning curve. It is an opportunity to rethink established internal systems and improve them across the board. The benefits up for grabs go beyond compliance with FDA regulations, and they will compensate the initial investment required.
One U.S.-based life sciences company took the initiative and invested in centralized content management and an integrated artwork system to help prepare for the 2014 UDI compliance date. The company used their updated systems to make 10,000 labeling design changes in just 10 days. Previously, this process involved 90 weeks of work, meaning the company has saved millions in costs.
Creative and forward-thinking medical device manufacturers can therefore tailor UDI preparation to the needs of their company, with a view to drawing out long term gains. The FDA compliance dates enable manufacturers to achieve compliance in stages; it is advisable to use this time to take a considered, strategic approach.