By: Ryan Randall, Senior Engineer, RQM+ (former FDA CDRH Lead Reviewer) and Kevin Go, Project Engineer, RQM+ (former FDA CDRH Lead Reviewer)

Since the beginning of the COVID-19 pandemic, CDRH has dealt with an unprecedented workload to ensure timely access to high quality health products that are essential to the nation’s pandemic response. Two years later, the pandemic response remains a top priority as CDRH continues to receive more than 100 Emergency Use Authorization (EUA) requests per month. Despite this, CDRH has also experienced an increase in the number of “conventional” premarket submissions (510(k)s, De Novos, Premarket Approvals (PMAs), and Q-Submissions (Q-Subs)), receiving close to 18,000 submissions in FY 2021.1 (See our recent RQM+ blog post, FDA CDRH 2021: A Year in Review, for our analysis of CDRH workload and performance insights from the past year).

In late December 2021, Dr. Jeff Shuren (Director, CDRH) and Dr. William Maisel (Director, Office of Product Evaluation and Quality (OPEQ), CDRH) published an FDA Voices blog post describing the Center’s ongoing workload challenges and CDRH efforts to transition back to “normal” pre-pandemic operations. They have made use of overtime for their employees, leveraged contractors from outside organizations to supplement review staff, and used funding support from Congress to hire additional staff. Importantly, they note that they anticipate a gradual transition back toward “normal” review timelines in 2022.2

Regarding In Vitro Diagnostic (IVD) products, CDRH had previously paused review of some non-COVID-19 IVD marketing submissions. However, all submissions previously paused due to resource constraints are now under review or have completed review. As of January 1, 2022, they have also resumed accepting Q-Submissions requesting feedback for IVDs that require or would likely require a PMA or De Novo submission, in addition to Q-Submissions that relate to COVID-19, a companion diagnostic, breakthrough device designation request, or an IVD that would have a significant public health impact. They hope to be able to accept all IVD Q-Submissions by the late spring or early summer 2022. For non-IVD products, CDRH expects all review divisions to be able to transition back to most of the MDUFA review timeframes in 2022.

As FDA begins to transition back to the normal course of business, companies marketing devices under an EUA or under an EUA Enforcement Policy should also be thinking about what comes next. To help guide companies during this time, CDRH released the following draft Guidance Documents for manufacturers of medical devices that were issued EUAs or were subject to relaxed enforcement policies during the COVID-19 pandemic:

Guidances on Transition Plans for Devices Distributed Under EUA or Enforcement Policies During COVID-19

During the pandemic, CDRH issued numerous EUAs and Guidance Documents about enforcement policies with relaxed regulatory requirements in an effort to meet the increased public need for certain necessary health products (e.g. in vitro diagnostic tests, ventilators, personal protective equipment). FDA recognized that it was important to ensure the availability of these products for the nation’s pandemic response. However, the EUAs and relaxed regulatory requirements were only intended to be a temporary measure. The newly published transition plan draft Guidance documents are intended to provide continued flexibility to manufacturers and other stakeholders to facilitate an orderly and transparent transition back to compliance with normal regulatory requirements without disrupting the product supply chain.

Key Takeaways Regarding EUAs

There are several important things to note if you currently market a device under an EUA:

  • FDA will provide 180 days advance notice in the Federal Register that an EUA will be terminated along with the reasons for termination. Until the termination date, manufacturers must continue to comply with the terms of the devices’ EUAs. FDA recommends that manufacturers with devices authorized under EUAs plan their post-EUA regulatory and disposition strategies now.
  • If you manufacture one of the devices in the table below, FDA recommends that you notify them as to whether or not you intend to submit a marketing application to continue distributing your product after the EUA termination date.
Table 1: EUA Transition Plan Devices

Product Code

Device Type

Classification Regulation

BSZ

Gas-machine, Anesthesia

21 CFR 868.5160

CAW

Generator, Oxygen, Portable

21 CFR 868.5440

BTT

Humidifier, Respiratory Gas (Direct Patient Interface)

21 CFR 868.5450

QAV

High Flow/High Velocity Humidified Oxygen Delivery Device

21 CFR 868.5454

CBK

Ventilator, Continuous, Facility Use

21 CFR 868.5895

MNT

Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

NOU

Continuous, Ventilator, Home Use

MNS

Ventilator, Continuous, Non-Life-Supporting

ONZ

Mechanical Ventilator

BTL

Ventilator, Emergency, Powered (Resuscitator)

21 CFR 868.5925

QOO

Tubing Connector for Co-venting

No corresponding CFR section

 

This will help FDA in resource planning for review and increased support to manufacturers. The guidance explains how to submit this notification to FDA and what information should be included.

  • If you intend to continue distributing a device after the EUA termination date:
    • FDA recommends submitting your marketing application to FDA with sufficient time for it to be accepted before the EUA termination date. As long as your marketing submission is accepted by FDA prior to the EUA termination date, you may continue to distribute your device while the marketing application is under review by FDA, even if it is after the EUA termination date.
    • Submissions should include a “transition implementation plan” that addresses your plans both for dealing with devices already distributed in the case of a positive FDA decision on your marketing application (e.g., 510(k) clearance, PMA approval, or De Novo granting), as well as in the case of a negative decision on your marketing application (e.g., not substantially equivalent determination or PMA disapproval).
    • If changes are made to your device for a marketing submission, you should discuss possible correction or removal strategies for devices already distributed, or FDA may request a recall of such devices.
  • If you do not intend to continue distributing a device after the EUA termination date:
    • FDA generally does not intend to request market removal of already-distributed EUA devices as long as several guidelines are followed. The guidance describes different guidelines depending on whether your device is single use vs. reusable, life-supporting/life-sustaining vs. non-life-supporting/non-life-sustaining, or an in vitro diagnostic device.
    • Depending on the classification of your device, you may need to either restore distributed devices to a previously FDA-cleared or approved version (e.g., earlier software version or component replacement), or update your labeling to ensure it accurately describes the product features and explains that it lacks FDA clearance or approval.
    • FDA expects to discontinue distribution of a device on the EUA termination date if the manufacturer has not submitted a required marketing submission for its device and had it accepted by FDA or if the manufacturer fails to receive a positive final decision on its marketing submission.
  • FDA recognizes that non-traditional device manufacturers that previously operated under different quality standards or requirements may face challenges in transitioning to a system that fully complies with the Quality System Regulation (21 CFR Part 820). FDA intends to take these considerations into account when making case-by-case compliance and enforcement decisions, and they explain how manufacturers may request an exemption or variance from a device Quality System requirement.

Key Takeaways Regarding Enforcement Policies

The transition plans for devices subject to enforcement policies are similar to those for EUAs, but they include more specifically defined transition phases. The following are key points to keep in mind if you manufacture one of these devices:

  • FDA will utilize a 180-day transition period, which will begin on an “implementation date” and will end with the device-specific enforcement policy guidance documents being withdrawn. The “implementation date” has not yet been announced, but it will likely be the date when the COVID-19 public health emergency (PHE) declaration expires. If the PHE declaration expires before the Draft Enforcement Policy Guidance is finalized then FDA will announce the implementation date in their final guidance, which would be at least 45 days after finalization of the guidance.
  • Phase 1: Begins on the implementation date. At this time, you should be following adverse event reporting requirements in 21 CFR Part 803 if not already doing so.
  • Phase 2: Begins 90 days after implementation date. At the start of Phase 2, you should be following the requirements for reports of corrections and removals from 21 CFR Part 806. If you plan to continue to distribute your device after the transition period, you should also be following the requirements for registration and listing from 21 CFR Part 807 Subparts B-D.

Similar to the EUA Transition Guidance, for the following devices, FDA requests that manufacturers notify FDA regarding their intent to submit a marketing submission or not to assist the Agency with resource planning for marketing submission review.

Table 2: Enforcement Policy Transition Plan Devices

Product Code

Device Type

Classification Regulation

BSZ

Gas-machine, Anesthesia

21 CFR 868.5160

CAW

Generator, Oxygen, Portable

21 CFR 868.5440

BTT

Humidifier, Respiratory Gas (Direct Patient Interface)

21 CFR 868.5450

QAV

High Flow/High Velocity Humidified Oxygen Delivery Device

21 CFR 868.5454

CBK

Ventilator, Continuous, Facility Use

21 CFR 868.5895

MNT

Ventilator, Continuous, Minimal Ventilatory Support, Facility Use

NOU

Continuous, Ventilator, Home Use

MNS

Ventilator, Continuous, Non-Life-Supporting

ONZ

Mechanical Ventilator

BTL

Ventilator, Emergency, Powered (Resuscitator)

21 CFR 868.5925

 

  • Phase 3: Begins 180 days after implementation date. The device-specific enforcement policy guidance documents will be withdrawn, and you will be expected to comply with all statutory and regulatory requirements applicable to your device (e.g., 21 CFR Part 820, 21 CFR Part 801 Subpart B, and 21 CFR Part 830), except as discussed below regarding premarket authorization.
  • FDA expects that any marketing submission for a device within the scope of the Draft Enforcement Policy Guidance should be submitted and accepted prior to the start of Phase 3 if you continue to distribute your device after the transition period ends. FDA does not intend to object to continued distribution of devices within the scope of the guidance after the start of Phase 3 if a marketing application has been accepted for review by that time and FDA has not yet taken a final action on the marketing submission.
  • Similarly to the EUA Transition Guidance, manufactures should include a proposed “transition implementation plan” in the marketing application to address devices already distributed in the case of a positive decision or negative decision on the marketing application.

FDA is hosting an upcoming webinar to help manufacturers navigate this challenging environment and understand how to ensure compliance with regulatory requirements after these transition periods. During the webinar they will describe recommendations and timelines for submitting marketing applications, provide examples to illustrate the policies, and answer questions about the draft guidance documents. Learn more on their events page.

How can RQM+ Help?

If you have a device that is under an EUA or subject to an enforcement policy, and your team is trying to figure out your regulatory requirements or plans to transition to a post-COVID world, RQM+ is here to help. We can help you:

  • Determine the transition requirements applicable to your device.
  • Develop a strategy and timeline for reaching compliance with normal regulatory requirements.
  • Create and submit a marketing application for your device that is currently marketed under an EUA or enforcement policy.
  • Provide support for interactions or meetings with FDA regarding your transition plans.

Contact us today or book a consultation to learn more about how we can support your devices. Incase you missed it, watch the recording of our recent RQM+ Live! episode "Year-end Review and 2022 Outlook on FDA Submissions", where our former FDA CDRH experts provide a recap of important FDA regulatory changes in 2021 and a forecast of what's to come in 2022.

RQM+_Live_46_Recorded-1

Sources:
1. Shuren, J., & Maisel, W. (2021, December 21). Looking Ahead to 2022 as FDA’s Center for Devices and Radiological Health Manages a Sustained Increase in Workload. Retrieved from U.S. Food & Drug Administration: https://www.fda.gov/news-events/fda-voices/looking-ahead-2022-fdas-center-devices-and-radiological-health-manages-sustained-increase-workload
2. FDA Roundup: January 4, 2022 (2022, January 4). Retrieved from U.S. Food and & Drug Administration: https://www.fda.gov/news-events/press-announcements/fda-roundup-january-4-2022
3. Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. (2021, December). Retrieved from U.S. Food & Drug Administration: https://www.fda.gov/media/155039/download
4. Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency. (2021, December). Retrieved from U.S. Food & Drug Administration: https://www.fda.gov/media/155038/download 

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