Aug 21, 2023
How to Transition Your Medical Device EUA to an FDA 510(k)
The COVID-19 public health emergency (PHE) declaration expired on May 11, 2023, which means termination of medical device Emergency Use Authorizations (EUAs) and pandemic-era policy enforcement is imminent. Manufacturers who previously secured an EUA need to take action now, especially if you intend to keep your products on the market.
FDA is requiring a marketing submission and full compliance with most regulations, including 21 CFR Part 820 (quality system regulation). Companies navigating medical device requirements for the first time may find themselves under pressure to comply by the proposed deadlines.
In this article, we will focus on steps you should take to continue marketing your device after your EUA expires, including timelines for complying with FDA regulations, navigating the FDA 510(k) process, and considerations for specific device types. Let’s dig in.
FDA Guidance on Medical Device and IVD EUA Transition Plans
In March 2023, FDA finalized two guidances that clarify next steps for manufacturers with medical devices or in vitro diagnostics (IVDs) on the US market under EUA or the pandemic enforcement policies:
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) Related to Coronavirus Disease 2019 (COVID-19)
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
Both documents are must-reads for understanding what happens when the pandemic-era authorization for a device is terminated. Here are key takeaways from the final guidances:
- FDA plans a phased transition away from the pandemic enforcement. The first phase began with the PHE expiration announcement on May 11, 2023. The transition period spans 180 days.
- Health and Human Services (HHS) will announce plans to expire an EUA in the Federal Register 180 days before its termination date. This announcement will start the clock for manufacturers of relevant devices to comply with federal regulations. However, manufacturers with EUAs are urged to begin preparing their submissions as soon as possible.
- If you intend to distribute devices after the EUA expiration date / transition period, your marketing submission must be accepted by FDA for substantive review before the EUA expiration date and / or the end of Phase 2.
Transition Timeline for Complying With FDA Requirements
Final enforcement policy transition guidance recommends that manufacturers consider the following phases to achieve compliance:
- Phase 1: The first phase began on May 11, 2023, when the PHE expired. At this point, FDA expects manufacturers to comply with 21 CFR Part 803 on medical device adverse reporting if they are not already doing so.
- Phase 2: The second phase began on August 9, 2023. FDA expects manufacturers to be in compliance with 21 CFR Part 806 and Subparts B, C, and D of 21 CFR Part 807 if they are planning to continue distributing devices after Phase 2.
- Phase 3: Finally, the third phase begins November 7, 2023, 180 days after the PHE expiration. Manufacturers are expected to be in full compliance with FDA requirements – including quality system regulation (QSR), unique device identification (UDI), and labeling – if they intend to continue marketing their device.
This transition plan was designed to minimize device supply chain disruptions and preserve FDA’s capacity to review marketing submissions in a timely manner. However, the typical 510(k) usually takes longer than 180 days to prepare. If your device requires a different submission type, such as a premarket approval or De Novo application, it may take even longer, especially if you require clinical trials. In this case, you should engage with FDA and begin compiling your submission as soon as possible.
A final action or decision from FDA is not required to continue distribution beyond the EUA termination. FDA won’t object to continued distribution of devices (in most cases) as long as your marketing submission has been accepted for review. However, you must stop distributing devices immediately if you receive a negative decision from FDA.
510(k) Process for Medical Devices With EUAs
If you’ve decided to continue selling your product after the EUA is terminated, you will need to move forward with FDA’s regulatory process, which, for most devices, means submitting an FDA 510(k). The 510(k) is a dossier of information about your device that proves it is substantially equivalent to another device already cleared by FDA, called a predicate. The predicate defines your device’s risk classification (Class I, II, or III) and its three-letter product code. You can search for already-cleared devices on the FDA 510(k) database.
If your device is very high risk (Class III) or you can’t find a suitable predicate, you may need to follow a different regulatory pathway:
- Class III devices may require premarket approval (PMA), which includes a more comprehensive submission dossier than the 510(k) and more rigorous regulatory obligations.
- Novel devices with no predicate may also require PMA, or you may be eligible for FDA’s De Novo.
To determine the best path forward, file an application for FDA to evaluate data on your device and determine its classification, called a 513(g) Request for Information. Or just ask us!
Additional FDA Submission Items for EUA Devices
In addition to the usual 510(k) requirements, FDA requests two additional items with marketing submissions for devices transitioning from an EUA:
- Cover letter indicating transition from EUA. The cover letter should indicate the device is currently under an EUA / enforcement policy. It should also include the EUA request number and submission number(s) for related premarket submissions.
- Transition implementation plan. This document should include an estimated number of devices in distribution, as well as outline your plans for distributed devices in the event of a positive or negative decision from FDA. Refer to the guidance for a detailed explanation of what to include in the transition implementation plan.
If you have never prepared an FDA submission – which is the case for many product manufacturers with EUAs – FDA’s Q-Submission/Pre-Submission Program allows you to discuss your questions with FDA reviewers.
FDA is making exceptions for certain life-saving and life-supporting devices = such as ventilators, certain anesthesia machines, portable oxygen generators, and tubing connectors = that will require a longer time frame for approval due to their high-risk profile and / or the potential negative impact of low supply. If you manufacture these products, you should send a Notice of Intent to the Center for Diseases and Radiological Health (CDRH) as soon as possible if you have not already done so. The notice should indicate if you intend to submit a marketing submission or outline your plans to discontinue distribution of the device by the EUA termination date. Refer to the guidance for a more detailed explanation of what to include in your Notice of Intent.
What EUA Device Companies Need to Know About QMS Compliance Under US FDA
Implementing a quality management system (QMS) that complies with FDA’s QSR 21 CFR Part 820 will be a major undertaking for manufacturers that have no previous experience complying with FDA regulations. FDA’s enforcement of QMS requirements involves a combination of premarket review [including documentation submitted with your 510(k) or PMA], facility inspections, postmarket surveillance, and corrective actions to ensure that manufacturers establish and maintain effective quality management systems.
However, FDA has indicated it will make QMS enforcement decisions on a case-by-case basis for EUA devices transitioning to standard compliance. To request a potential exemption or deferment, submit your QMS exemption request to the FDA within 90 days of your EUA termination announcement.
Take the Next Step Toward FDA Compliance
FDA clearance for Class I or II devices can take at least 12 to 18 months. If your device is high risk or has no predicate, plan on compliance taking much longer. With FDA’s transition plan already in motion, many companies are rushing to get their submissions ready before the deadline. However, you don’t have to do this alone. Oriel STAT A MATRIX can help you get into full compliance with FDA QSR, train your team, and get you ready to submit your 510(k) or PMA submission.