Following the declaration by the Department of Health and Human Services (DHS) of the COVID-19 Pandemic public health emergency (PHE), the U.S. Food and Drug Administration (FDA) began to issue Emergency Use Authorization (EUA) approvals and enforcement policies for devices used to mitigate the spread of the SAR-CoV-2 virus, including the diagnosis, treatment or prevention of Coronavirus Disease (COVID-19).
From the outset, the FDA made it clear that the above EUAs and enforcement policies would only be in effect during the PHE. On, December 23, 2021, the Agency acknowledged the general need for a transition process back to ‘normal operations’ and released two draft guidance documents that introduce their proposed transition plans, which include:
- Transition Plan for Medical Devices Issued Emergency Use Authorizations (EUAs) During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
- Transition Plan for Medical Devices That Fall Within Enforcement Policies Issued During the Coronavirus Disease 2019 (COVID-19) Public Health Emergency
These draft guidances describe the processes and requirements for both manufacturers who intend to continue or cease marketing their devices at the end of the PHE. As is standard practice with draft guidances, the Agency requests public comments for both draft documents, due by March 23, 2022. Comments can be submitted electronically to https://www.regulations.gov or written and addressed to the FDA Dockets Management Staff.
- The FDA understands that device manufacturers need time to transition from policies and operations implemented during the COVID-19 PHE to normal operations, and has described a Transition Plan for Devices Authorized under EUA and a Phased Transition Plan for Devices that Fall within COVID-19 Enforcement Policies.
- The Agency proposes a 180-day transition period prior to ending EUAs and enforcement policies, and will publish advance notice of the termination date in the Federal Register.
- The transition plans provide recommendations regarding preparation and submission of marketing submissions and manufacturers’ actions if they do/do not wish to continue device distribution.
- The FDA will allow for continued distribution of devices brought to market under an enforcement policy or EUA if a marketing submission [e.g. 510(k)] is submitted to the FDA and passes the Refuse to Accept (RTA) process prior to the end of the aforementioned 180-day transition period.
- If a manufacturer decides to discontinue device distribution on or before the 180-day transition, the Agency will allow already distributed devices to remain in the field, but may require certain activities be completed based on device type.
- If a manufacturer decides to continue marketing a device after the 180-day transition period, the FDA will allow continued distribution of devices so long as the manufacturer has a marketing submission that has been accepted (through the RTA process) by the FDA and is pending an FDA decision. The manufacturer will be expected to comply with all other regulatory requirements (e.g. 21 CFR Parts 803, 806, 807, and 820) by day 180.
- If a negative decision is received regarding a marketing submission, the FDA may request a recall.
- It is critical for impacted manufacturers to start planning for their EUA or enforcement action transition plan sooner rather than later.
Enforcement Policy Guidance
This guidance identifies applicable enforcement policy guidance documents that are in scope, and the FDA has indicated that they will edit the list of guidances as needed.
For devices currently marketed under enforcement policy, the 180-day transition timeline will be broken into three phases and the implementation date (starting date) will be no less than 45-days from the finalization of the guidance. The phases will have different impacts on manufacturers based on their decision to continue or cease marketing of their device following the 180-day transition date.
This guidance applies to devices issued an EUA during COVID-19, and does not include devices that had EUAs that were previously revoked. The FDA has proposed that an advanced notice of termination of an EUA will happen 180-days before the EUA termination. During this 180-day “transition,” manufacturers must continue to comply with the terms of the EUA.
Manufacturers who PLAN to continue marketing their device…
For both EUA and enforcement policy guidances, the FDA has indicated that manufacturers planning to continue device marketing should have a marketing submission accepted before the end of the communicated transition period. It is not enough for a manufacturer to simply submit their marketing submission to the FDA, but rather the submissions must be formally accepted through FDA’s RTA process.
For 510(k), Premarket Approval (PMA) and De Novo submissions, the FDA will complete their Acceptance Review within 15 calendar days of submission receipt. However, the submission may not be accepted (i.e. designated RTA) or may go on RTA-hold while the FDA requests information or clarity. It will be imperative for manufacturers to adjust their submission timelines accordingly.
For devices under either EUA or enforcement policy, the Agency has requested that the marketing submission include a “transition implementation plan” discussing the planned disposition of distributed devices. It must also take into account changes to the distributed devices as compared to those under submission review.
The FDA will allow continued device distribution following the transition timeline if the submission has been accepted and while the submission is still under review. However, specific to devices marketed under EUA, the EUA guidance states that during this time period, any device labeling should be modified to state, “that the product was authorized under an EUA issued during the COVID-19 PHE and remains under FDA review for clearance or approval.” Distribution of devices marketed under EUA or enforcement policy must cease if the manufacturer receives a negative decision on the marketing submission (e.g. not substantially equivalent [NSE]), withdraws submission or fails to provide a complete response to an FDA Additional Information (AI) request.
Note that FDA has requested that certain life-supporting or life-sustaining devices currently marketed under an EUA or enforcement policy submit a “Notification of Intent” that will notify the Agency if the manufacturer intends to submit a marketing submission. The goal of this notification is to allow the Agency to adequately plan for the resources required to complete marketing submission reviews and strongly encourages early submission. The guidance outlines the devices that fall within scope of this request, and details the contents that should be included within the notification.
Manufacturers who DO NOT PLAN to continue marketing their device…
If a manufacturer does not intend to continue marketing their device after the transition period, the Agency has provided guidance on how to appropriately disposition already distributed devices. Device disposition has been differentiated based on criticality (e.g. life-supporting or life-sustaining), use (e.g. reusable or single-use) and clearance/approval history. Overall, the FDA will not require removal of these devices provided that the manufacturer follow certain requirements for their specific device type (e.g. labeling or design requirements).
Enforcement Policy Transition Plan Details
The guidance document detailing the proposed transition plan for devices currently marketed under enforcement policy has included more details on the “phased transition.” The below table applies only to manufacturers who PLAN to continue marketing devices that have been marketed through enforcement policy during the COVID-19.
|Phase||Timeline (Days)||Manufacturer Requirements|
|1||0-89||· Follow Adverse Event Report (21 CFR Part 803)
· Submit any stored Adverse Event Reports
· Begin to prepare marketing submission, as required
|2||90-179||· Register and list (21 CFR Part 807)
· Submit reports of corrections and removals (21CFR Part 806)
· Specific product codes should submit Notification of Intent to the FDA
· Submit marketing submission to the FDA with enough time to pass the Refuse to Accept program (RTA)
· Marketing submissions should include a “transition implementation plan”
|3||180||· If the marketing submission is accepted, devices can continue to be distributed until final FDA decision
· All applicable statutory and regulatory requirements apply (e.g. Quality System [21 CFR Part 820])
· If the manufacturer receives a negative decision on the marketing submission (e.g. not substantially equivalent [NSE]), withdraws submission or fails to provide a complete response to an FDA Additional Information (AI) request, distribution must cease
The below table applies only to manufacturers who DO NOT PLAN to continue marketing of their device that has been marketed through the COVID-19 PHE enforcement policy.
|Phase||Timeline (Days)||Manufacturing Requirements|
|1||0-89||· Follow Adverse Event Report (21 CFR Part 803)
· Submit any stored Adverse Event Reports
|2||90-179||· Discontinue distribution prior to start of Phase 3 (day 180), in accordance with the disposition requirements associated with the device|
|3||180||· Comply with statutory and regulatory requirements for devices as required (e.g. adverse event report [21 CFR Part 803])|
How Can NAMSA Help?
Manufacturers of devices that are currently marketed under EUA or enforcement policy should start to plan for their transition after the COVID-19 PHE comes to an end. NAMSA’s Regulatory consultants, including our IVD specialists, can help you navigate this transition through creating strategies, supporting Pre-Submission discussions with FDA, developing marketing submissions or simply talking through your current thoughts on the transition.
Get in touch with us today at: namsa.com/locations-contact/
Or, learn more about our regulatory and IVD services and solutions below:
Kelly Kucharczyk, RAC
Kelly Kucharczyk, RAC, currently serves as NAMSA’s Associate Director of Global Medical Writing and US Regulatory and Quality Services. Prior to joining NAMSA, Kelly worked in the medical device industry for a decade, leading regulatory teams, developing global marketing access pathways and tackling the regulatory aspects of business development through M&A. She is passionate about helping clients expedite their marketing application timelines through early and on-going development of regulatory strategy, critical assessment of testing and communication with regulators.