4 Ways IVD Product Development Can Navigate the EUA in the Time of COVID-19

COVID-19 has changed the way companies of all sizes approach IVD product development. Before the emergence of SARV-CoV-2, IVD developers and manufacturers seeking approval in the U.S. were focused on meeting the stringent requirements of the FDA using the design for regulatory (DfR) concept. But as the global impact of the pandemic increased, with no approved instruments or assays to detect or diagnose the virus, FDA activated the emergency use authorization (EUA) pathway to IVD approval, which significantly relaxed the Quality Systems Requirements (QSR) outlined in 21 CFR 820 and completely reshaped DfR around this modified approval pathway.

The Past and Present of the EUA in IVD Development

Activating the EUA pathway opened the floodgates for IVD companies, providing a pathway for rapid review and approval, as long as they could demonstrate safety, reasonable efficacy, and quality. In the past, the EUA process had been used sparingly. It was first put in place in response to the 2009 H1N1 pandemic and deemed a success by HHS: Its implementation led to the development of diagnostic tests and near-immediate response by public health labs, enabling effective monitoring of viral spread.

Now, with over a year since the FDA authorized the emergency use of IVDs to detect and diagnose COVID-19, over 300 MDx, antigen-based, laboratory-developed, and serology tests have received an EUA. With the ongoing nature of the pandemic, many more IVD companies are developing EUA strategies to enter the market. However, EUA is not often used, so companies are uncertain about how to navigate the process and how to best ensure approval.

To help you through, we’ll give you a high-level overview of the steps along the way to approval and give you some key strategic recommendations for your EUA submission.

A Roadmap to EUA for IVD Companies

The first time negotiating any regulatory process can be confusing. In the case of EUA, FDA has taken action to streamline the submission and educate IVD developers about the information and data required.

Here’s a look at the key steps.

Pick Your Submission Template

FDA has done you the good deed of providing templates for molecular or antigen diagnostics and serology tests. They include the most current guidance for the information and data required for a pre-EUA and/or EUA submission and highlighted areas that need to be filled in by you and your development and manufacturing teams.

You can think of it as the least fun game of Mad Libs you’ll ever play. While not necessarily fun, it does provide a sturdy framework for quickly and efficiently preparing your submission.

Submit a Pre-EUA

As you are in the early stages of design and development, you can submit a pre-EUA with your completed EUA package to the email address included in the template. If you are developing a novel test for which there is no template, you can make a personalized Pre-EUA request to FDA. They’ll send you a questionnaire and, if granted, a PEUA # will be assigned along with a reviewer. You’ll be able to work with your reviewer to get all required data and information, then submit an EUA for full review and decision.

EUA Submission

The final EUA submission package contains a description of the intended use, interpretation of results, and performance evaluation, which is the most involved part of the submission package. The templates include detailed instructions for acceptable methods for measuring stability, limits of detection, sensitivity, cross-reactivity, reproducibility and repeatability, fresh vs. frozen sample comparisons, flex, usability, clinical evaluation, reference testing, EMC/EMI testing, cybersecurity, and system and software validation. This data is an integral part of the submission package. Once submitted, FDA will review and make a final decision. In general, the EUA submission package and approval process are similar to that required for a 510(k) submission, with much less stringent quality and efficacy requirements.

Key Considerations for a Successful EUA Submission

Now that we’ve outlined the process, let’s look at some strategic recommendations on how to get your IVD instrument or assay to market in the fastest way possible and one that guarantees its long-term position in the market. At some point, FDA will close the EUA as a pathway to approval and it’s unclear what will happen to IVD product developers and manufacturers who are producing IVDs or other medical devices that are only authorized for emergency use.

Here’s some guidance for achieving EUA approval and how to best protect your product’s position in the marketplace against the eventual end of EUA.

Get Your Pre-EUA Questions Answered and Do Your Research

It’s better to raise any concerns with the FDA early in the design process. This can be done by preparing a pre-EUA that best represents the final EUA submission package. Do some research and see if similar IVD instruments or products have gotten approval and learn what you can from their EUA summary.

If you have questions about the EUA templates or any novel technology, analyzer, or software that you are developing and what product category or template (if any) it falls under, email the FDA with your questions. You can also attend the FDA Town Hall meetings, where you can ask your questions directly.

Expert consultants or IVD development and manufacturing partners, like Gener8, can provide strategic guidance on your path to market too. They have decades of IVD commercialization experience and can answer your questions from a place of authority and experience from real-life dealings with FDA.

Protect Your IVD Approval With a Follow-up 510(k) Submission

With the possibility that the EUA approval pathway will eventually end, many products could be left in the lurch and be pulled from the market. To adequately protect against this possibility, Fred Trimble, VP of Quality and Regulatory at Gener8 recommends pursuing a 510(k) submission after an IVD or medical device is granted an EUA. “A lot of the paperwork is the same between the two submission packages,” Trimble explains. “For example, safety and performance testing in compliance with IEC 60601 and IEC 61010 is generally required for both an EUA and 510(k).”

The biggest difference is with QSR, design controls, and risk management. “You’ll get much greater latitude in these areas with an EUA, compared with a 510(k),” Trimble continues, “so we usually recommend that IVD companies develop the EUA submission without compliance with  the QSR, where it would materially impact their development timeline, then follow up with the additional documentation and rigor required for a 510(k) so that IVD developers are protected when EUA inevitably ends.”

Bring Consumables and Instrument Design Together

One of the biggest benefits of pursuing an EUA is the speed with which you can commercialize your product. To fully capitalize on this fast-tracked approval process, you also need your IVD development to move quickly. An IVD may have an instrument component and consumable component, and oftentimes companies may have expertise in one or the other or approach development for each of these sequentially. “It’s rare for IVD companies to have the broad, internal, systems-level knowledge that we have at Gener8,” adds Trimble. “Having that expertise under one roof and doing development of each in parallel is efficient and can really expedite design and development timelines.”

CDMOs and IVD Development: An Integral Resource for Regulatory Consulting and Expertise

It’s rare for medical device companies, especially startups and mid-sized companies, to have all the regulatory and design proficiency required to bring an IVD product through regulatory approval and to market. Most companies need more than just design and regulatory expertise, they need guidance and broad knowledge about the entire product development process. CDMO’s and IVD consultants can help bring in-depth industry expertise and the latest real-world regulatory experience to your project. When pursuing an EUA, it’s helpful to have this expertise so you have realistic expectations of how long the process will take and just how much you can push timelines. Bringing an experienced development partner can also save on costly redesign, additional testing, resubmissions, and ultimately, lost sales.

What’s Next for the EUA?

The only thing that’s constant is change and the EUA is no exception. As discussed above, the EUA pathway won’t last forever, and the regulatory landscape will shift once again. Finding a regulatory pathway that’s suitable for you and your IVD product requires you to take confident action, even in uncertain times. Follow the suggestions above and partner with an authority in IVD product development.

At Gener8, we’ve helped over 400 clients successfully achieve their project goals. Our engineering, scientific, and regulatory teams bring expertise in the design, development, and manufacturing of plastic consumables for IVD products and IVD instruments. We can guide you through FDA’s EUA process to push your product to market as quickly as it can safely and effectively go and ensure it stays there for the long-term.

To learn more about our expertise in IVD product development, check out our services for medical product development and manufacturing.

Posted in