Insight #1:

Common Issues with Dual 510(k) / CLIA Waiver Submissions

When pursuing dual submissions for a 510(k) clearance and CLIA waiver, many teams encounter common pitfalls that can slow down or complicate the process. Here are some key issues to keep in mind:

• Addressing Common Questions Early: Dual submissions often raise specific questions from the FDA, especially around the device’s intended use and operator requirements. It’s helpful to anticipate these and provide detailed responses upfront.
• Selecting Testing Sites and Operators: Ensuring your testing sites and operators are well-defined and appropriate for CLIA waiver criteria is critical.
• Comprehensive Risk Analysis and Flex Studies: One major issue is an incomplete risk analysis. Many teams underestimate the need for sufficient Flex studies to show the device’s resilience across various conditions, which is essential for both 510(k) and CLIA requirements based on risk.
• Appropriate Allowable Total Error (ATE) and Limits for Erroneous Results (LER): These statistical metrics are used to evaluate the level of agreement between two testing methods. Often, teams start with an ATE that’s too broad. Engaging with the FDA to define an ATE and LER appropriate for the device’s intended use can streamline the review process.
• Simple Device Design: The more straightforward your device design, the easier it is to support a CLIA waiver. Usually, the device is fully automated and uses unprocessed specimens involving no operator calibration and calculations.

For more detailed guidance on CLIA Waiver Applications, the FDA provides a helpful resource here.

If you’re navigating the complexities of CLIA waiver submissions, MDC Associates is here to help. With our proven experience, we can streamline your path to demonstrating simple, safe devices for point-of-care use. Reach out to discover how we can support your journey.

Insight #2:

Understanding Emergency Use Authorization (EUA)

Unlike standard pre-market submissions, EUAs are reviewed based on priority rather than in a traditional queue. The FDA prioritizes EUA submissions based on public health needs, considering factors like the availability of other similar tests and the urgency of the situation. This means that a submission may move forward faster or slower depending on the current landscape and demand.

For companies seeking an EUA, it’s essential to understand that these submissions are managed dynamically and in response to evolving public health needs. This flexibility is designed to ensure that the most urgently needed diagnostic tools reach the public as quickly as possible.

Currently, the FDA is encouraging manufacturers to pursue standard 510(k) submissions for COVID-19 diagnostic tests rather than relying on EUA. By shifting to 510(k) clearances, COVID-19 tests can achieve longer-term market stability, which is increasingly important as emergency conditions subside.

For emerging health threats like Mpox, however, the FDA continues to prioritize EUAs, recognizing the urgent need for effective diagnostics in controlling outbreaks.

This strategic focus not only encourages manufacturers to seek 510(k) approvals for COVID-19 but also reinforces the FDA’s commitment to public health responsiveness by rapidly authorizing new tools for emerging threats like Mpox.

Our team at MDC worked closely with many IVD EUA manufacturers throughout the COVID-19 pandemic and are supporting their transitions to 510(k) clearance. Contact us if you’re considering an EUA submission or planning your path through a 510(k) to leverage our expertise in navigating FDA’s EUA process and prioritizing rapid access while ensuring compliance and robust evidence.

For more on Emergency Use Authorization visit FDA’s consolidated summary here.

Insight #3:

Breakthrough Device Designation (BDD): Timing and Key Criteria

One common challenge with Breakthrough Device submissions is that some manufacturers submit too early, often before the device has moved beyond the concept stage. For a successful Breakthrough Device submission, it’s crucial to understand and meet the FDA’s criteria.

Device and Data Requirements (Criterion 1): To meet Criterion 1 (to provide a more effective treatment or diagnosis for a life-threatening or irreversibly debilitating disease or condition), manufacturers must have a working device prototype and data demonstrating both technical feasibility and clinical success. Submitting prematurely—without this foundational evidence—often results in delays or denials. The FDA expects a device to be past the concept phase and considers the totality of information regarding the proposed device for functionality and benefit.

This data typically includes proof-of-concept studies, early-stage clinical or analytical performance data, and technical assessments that show the device functions as expected

To qualify for the FDA’s Breakthrough Device Designation (BDD), a device must meet Criterion 1 and one of the following Criterion 2 options; device represents breakthrough technology, no approved or cleared alternatives exist, device offers significant advantages over existing approved or cleared alternatives and device availability is in the best interest of patients.

Consideration of Patient Choice (Criterion 2): Criterion 2 allows manufacturers to include patient choice as a factor. This means that if the device offers a unique advantage or choice for patients—such as reducing invasiveness or increasing accessibility—this can strengthen the submission. However, patient choice alone is typically not sufficient; it should be paired with demonstrated clinical benefits.

MDC has a track record in securing Breakthrough Device Designations and can help you demonstrate transformative potential and achieve accelerated FDA review. Contact us iIf you’re considering a Breakthrough Device Designation submission.

Insight #4:

FDA’s Reclassification Process for Class III IVDs

CDRH has initiated the reclassification process for most high risk IVDs in infectious disease and companion diagnostics. In September this year FDA proposed the reclassification for HBV assay devices and has finalized the order to reclassify CMV DNA assay for transplant patient management.

This reclassification is usually possible if there is sufficient evidence to demonstrate that a combination of general and special controls (for Class II) can reasonably assure the device’s safety and effectiveness.

Reclassification Pathways:

• De Novo Classification: Manufacturers may request the De Novo classification pathway if their device has no legally marketed predicate but poses a moderate risk. If granted, this results in Class II designation with special controls.
• Down-Classification: The FDA itself may initiate reclassification by evaluating evidence from adverse event reports, regulatory submissions, and new technological developments.

Benefits of Reclassification:

• Streamlined Approval: Class II devices can enter the market via the 510(k) or de novo pathway, typically a less burdensome process both time and cost wise than PMA.
• Wider Access and Innovation: Reclassification can encourage more manufacturers to develop or improve similar devices, benefiting patient access and advancing healthcare technology.

We invite you to benefit from our team’s knowledge of infectious disease and CDx as well as De Novo pathways. We can work with you to ensure a clear strategy for regulatory success in innovative diagnostics.

And that’s a wrap of the key takeaways from the November 2024 FDA IVD Roundtable. Don’t forget to subscribe to our IVDwise blog to stay ahead of the latest insights and updates in the IVD industry.