The US Food and Drug Administration (FDA) published a draft guidance document in December 2021 outlining transition plans for medical devices currently marketed under Emergency Use Authorizations (EUAs) during the COVID-19 public health emergency (PHE). The FDA has issued EUAs for a vast array of medical devices during the pandemic including ventilators, infusion pumps, personal protective equipment, in vitro diagnostics and more.
Dr. Jeffrey Shuren, Director of the Center for Devices and Radiological Health (CDRH) stated in a recent hearing that the agency is taking steps to narrow their focus to EUA devices that are especially important in the pandemic fight.
“Over the coming months the goal really is to start turning off the spigot on EUAs because there’s enough product out there,” he said.
Acknowledging that the COVID-19 emergency will not last forever, the FDA’s draft guidance proposes a transition path back to “normal operations,” i.e., compliance with the Federal Food, Drug, and Cosmetic Act (FDCA) and regulatory requirements.
For certain reusable life-supporting or life-sustaining devices, such as ventilators, portable oxygen generators and anesthesia gas machines, the FDA calls for manufacturers to notify the Agency of whether they intend to submit a marketing submission to continue distributing their product beyond the EUA termination date.
The FDA requests that manufacturers of these devices submit the following information as soon as possible after the guidance is finalized: a “notification of intent” including contact information, the EUA request number, the submission number and whether the manufacturer plans to submit a marketing submission.
Manufacturers are asked to submit their marketing submissions for any devices (various scenarios can be found in the guidance’s Appendix) they intend to distribute after the EUA termination date “with sufficient time for the submission to be accepted by FDA before the EUA termination date.” The EUA draft guidance recommends that device manufacturers include a “transition implementation plan” along with any new marketing submission.
The transition period, which would begin 180 days after the end of the PHE, would allow manufacturers, healthcare facilities, and other stakeholders to avoid supply disruptions and product shortages. Following the transition period, manufacturers who want to continue selling covered devices would be expected to comply with all the usual regulatory requirements.
The FDA’s Enforcement Policy Transition Plan is broken into three phases:
- Phase 1 begins on the plan’s implementation date (i.e., the end of the PHE), no less than 45 days following finalization of the draft guidance. During Phase 1, manufacturers should begin following 21 CFR Part 803 for adverse event reporting. Manufacturers of reusable, life-supporting or life-sustaining devices should provide reports to FDA to assess potential supply shortages.
- Phase 2 begins 90 days following the plan’s implementation date Prior to Phase 2, manufacturers should have already begun complying with 21 CFR Part 806 regarding reports of corrections and removals requirements; companies intending to remain on the US market should also follow 21 CFR Part 807 requirements for registration and listing and submit 510(k)s or other premarket applications to FDA.
- Phase 3 comes into effect 180 days after the plan’s implementation date. At this point, FDA will withdraw all COVID-19-era enforcement policy guidances and begin requiring manufacturers to meet all standard regulatory requirements applicable to their devices. Manufacturers that have not applied for full FDA registration will be required to withdraw their devices from the US market.
The Enforcement Policy Transition Plan does not include diagnostic tests commercialized in accordance with the FDA’s Policy for Diagnostic Tests for COVID-19. Due to the short supply of COVID-19 diagnostic tests, the FDA also will permit the continued distribution of COVID-19 diagnostic tests marketed under an EUA for up to two years after the termination date, or until the product’s expiration date, whichever is less. The FDA’s virtual Town Hall series provides the most up-to-date information for SARS-CoV-2 test developers.
Not only does FDA expect immediate adherence to certain regulatory requirements once the transition period begins, but it may also take greater than 180 days to generate data and draft a premarket submission. Much of the information required for a 510(k) or De Novo request may have been generated as part of an EUA request or in the development of a product that will meet an EUA enforcement policy, but if clinical trial data is required, this may not be sufficient time for completion.
For scenarios not addressed by the draft guidance, FDA recommends that manufacturers initiate discussions with the Agency through the Q-Submission Program to develop a plan to address their specific concern.
Industry groups have flagged that the Agency’s proposed guidances does not give companies enough time to submit a premarket application and to make labeling changes (comments on the draft guidance closed on March 23, 2022). AdvaMed states the agency has greatly underestimated the amount of time and effort it takes to update product labeling, and instead proposes manufacturers be allowed to update their labeling electronically for consumers to get additional information.
Shuren said that the FDA is still reviewing the comments on the guidance but encourages manufacturers to not wait for the PHE to be over to transition their products to regular marketing status. He said if device makers know they plan to make that transition, they should come to FDA as soon as possible with their data and start the process.
“Also remember the product is already on the market and we’re going to focus on new product applications but we’re not going to disenfranchise anyone who already has their product on the market,” he added.
Although there is no clear end date for the COVID-19 public health emergency, the FDA has now provided more concrete timelines and policies for manufacturers that intend to remain on the US market once their EUA designations expire, as well as for firms that will not. Where possible, the FDA said it “strongly encourages” manufacturers to work to complete such submissions “well in advance” of the start of Phase 3 to avoid potential delays created by a large influx of new submissions.
Alexandra (Sandy) Reid is a StarFish Medical QA/RA specialist. She brings years of experience working in the industry. Sandy supports the QA/RA team in helping clients develop and deliver FDA Approved or Cleared Medical Devices.