A Summary of Staci Kearney’s presentation at the Digital Diagnostic Summit 2024
The Current State of the FDA’s Final Rule
On May 6, 2024, the FDA issued its final rule on LDTs, and the first compliance milestone, in May 2025, is coming up fast. Do you feel confident that your lab is ready for these changes?
As evidenced by the 500-page preamble explaining the what and how of their decision, putting this rule into practice is complex and requires some strategic planning. The FDA approval process will now be much longer, more expensive, and more labor-intensive for laboratories than the current process for LDTs, so it’s imperative that we continue to take educated steps toward compliance as new requirements are rolled out.
Together, we’ll review a high-level overview of the rule. We’ll also look over a potential road map, consider factors that could affect implementation, and walk you through a correct but tailored approach toward full compliance.
Stage 1: Complaints, Medical Device Reporting, and Corrective and Removal Reporting
The first compliance milestone, set to go into effect on May 6, 2025, is all about complaints, medical device reporting, and correction and removal. Luckily, since both CAP and CLIA require you to handle complaints, many labs should already have some form of complaint process in their QMS. However, it is likely to require updating to meet FDA requirements. Medical device reporting should also be part of your current processes already.
You may encounter correction and removal less frequently. Removal means getting the tests off the market and pulling in. However, because laboratories use tests within your lab, the process would look different from that of traditional manufacturers.
Stage 2: Registration, Labeling, and Investigational Use
Generally, the requirements in the stages get progressively harder to meet, and stage 2 is more difficult than the first. The three requirements for this stage are registration and listing on the FDA’s database of manufacturers and devices, labeling, and investigational use. Therefore, at this stage, you announce that you’re working toward compliance in the public domain. This occurs by registering and listing your lab and tests in the FDA’s registration database. You’ll also need to plan to pay a fee of around $10,000, which will occur annually moving forward.
Guidance on labeling hasn’t been very clear yet, so this is an area where you can wait and watch for new information before making any changes.
Laboratories (especially if you do clinical research) are already subject to investigational use FDA regulations, but the new ruling clearly shows that being CLIA-certified isn’t enough.
Stage 3: Quality Management System
This implementation phase is definitely more complex than the first two. If you’re offering LDTs, stage 3 is about bringing your Quality Management System (QMS) up to FDA standards. It’s definitely doable to weave FDA QMS requirements into your current CAP/CLIA-certified QMS. Still, it will take a lot of work and likely could cause some disturbance in your current operations, especially for your lab team, which will directly experience the changes. The best approach is to start this process early and introduce changes slowly so your lab personnel understand the differences and what you’re asking.
As a new effort, you’ll need to plan for a formalized design control process with specific steps to address test development requirements. You may need to create a specialized team and even bring on additional expert personnel to manage that process, including a quality leader who understands design control.
Stages 4 & 5: Regulatory Review
In the final stages of the rule rollout, you’ll need to prepare a regulatory submission application that meets the level of evidence required for your Class of LDT. This submission will undergo review by the FDA, which also carries a fee. Like your QMS, preparing these types of submissions will likely require an expert regulatory affairs professional to manage the process.
Five Tips for Moving Forward
Now that you understand the FDA rule on a high level let’s talk about how to begin approaching these changes for your lab and navigating these compliance steps as bite-sized steps you can work through with your laboratory teams and administrators.
1. Observe and Plan
It’s important to first acknowledge that there’s a lot of possibility for changes to these guidelines and milestones over the next four years. Things like lawsuits, changes in the FDA’s priorities, and a possible return to legislation by Congress could potentially affect the scope and implementation of the final rule.
So, begin to implement some of these steps mindfully—while staying observant about possible changes and planning to meet future milestones.
2. Categorize Your Test
While the rule requires that some existing and new LDTs comply with all stages of the compliance transition, certain categories of tests may have to comply only with certain stages. For example, if you had an LDT marketed before May 6, 2024, you have continued enforcement discretion and must meet only certain stages or aspects of those LDTs. “Unmet medical needs” is another category where many laboratories will probably have the opportunity to reduce the compliance requirements to offer assays they’re running now to patient populations they need to service and who will continue to need these tests.
There is also some enforcement discretion for modified, FDA-cleared IVDs (not a significant modification) and LDTs approved or with an approved exemption under NYS-CLEP. Though, full compliance with stages 1-3 is necessary.
However, if you do not fall into one of the categories defined in the rule, full compliance with the rule will be required. During this final rule transition enforcement phase, it’s still okay to offer LDTs and bring new LDTs online as long as you comply with the stages that have gone into effect.
3. Expect Change
While we acknowledge the possibility of pushback and alterations to the final rule, assuming that it will be overturned completely is risky. A better mindset is to avoid overdoing what we don’t understand and follow FDA updates as you can. Overall, preparing to meet these milestones is recommended, but keep an eye out for new developments and contingencies that may apply to you.
Elevation Strategic Development is an excellent resource for updates that are specific to you. You can also find many resources on our YouTube account.
4. Manage Resources Effectively
It’s also important to weigh your resources against upcoming changes you’ll need to make and manage your compliance risk well. Keep priorities like focusing on your patients in mind as you decide how and when to implement changes and updates.
5. Find Help When Needed
If the new compliance standards feel overwhelming and confusing, you’re not alone. Every laboratory is different, and managing these changes while maintaining daily operations and staying informed about changes is a lot to manage alone.
Our team can help! Please get in touch with us at https://elevationsd.com/ if you’d like to work with us as you navigate these changes.
This article was featured in the Digital Diagnostic Digest, a quarterly magazine by the Digital Diagnostic Summit. To read more stories like this one and for other digital pathology news and tips, subscribe to the digest today.
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