FDA’s top 10 tips to transition your COVID-19 products

Regulatory NewsRegulatory News | 22 November 2022 |  By 

FDA's William Maisel spoke at the 2022 Medtech Conference in Boston. (Source: Ferdous Al-Faruque)

During the COVID-19 pandemic, the US Food and Drug Administration (FDA) allowed more than 4,000 medical devices and diagnostics on the market under emergency use authorization (EUA) or enforcement discretion. Those products can’t stay on the market indefinitely – and a top agency official has some tips on how to transition such products to traditional marketing pathways.
 
Focus recently spoke with William Maisel, chief medical officer and director of the Office of Product Evaluation and Quality at the Center for Devices and Radiological Health (CDRH). Here are his top 10 tips on transitioning products.
 
1. Understand the transition plan
 
In December 2021, FDA published two draft guidances outlining a risk-based transition plan that would give manufacturers with EUAs and those with products under agency enforcement discretion 180 days’ notice to either stop marketing their products or seek permanent marketing authorization. (RELATED: FDA proposes 180-day transition before terminating COVID-19 EUAs, enforcement policies, Regulatory Focus 4 January 2022)
 
“The plan that we proposed is intended to facilitate continued patient, consumer and healthcare provider access to COVID-related devices,” said Maisel. “Our goal is an orderly and transparent transition consistent with the agency's mission.”
 
“Having a common understanding of the purpose, intent and approach of the transition planning will really help sponsors understand the purpose of many of the recommendations in the guidance documents,” he added.
 
2. Start thinking about your transition plan now
 
Maisel said manufacturers should start thinking about their transition plan now so they don’t end up trying to figure things out at the 11th hour. He added that there are timelines set out in the guidances and that FDA has tried to give manufacturers ample notice so they can thoughtfully plan how they want to transition their products.
 
“Our draft guidances were published in December 2021, so we're coming up on a year already and our transition plan once the implementation starts will be an additional six months,” said Maisel. “We believe that is ample time for companies to plan and implement their plan.”
 
“It's important that companies begin planning, if they haven't already, so that they can make best use of the time that they do have,” he added.
 
3. Do a gap analysis
 
As companies begin thinking about their transition plan, Maisel recommended conducting a gap analysis of the pre- and post-transition regulatory expectations for their devices. For example, he said that some companies may realize they need to submit a premarket application to meet their post-transition regulatory expectations and may also need to comply with regulations such as quality manufacturing expectations, adverse events reporting and unique device identification (UDI) requirements.
 
“The point is companies should look at what is expected of them now to market their product and then look at what we outline in the transition policies and think about what's going to be needed so that they can plan accordingly to meet the regulatory expectations,” said Maisel.
 
He added that FDA outlined its agency’s expectations thoroughly in the draft guidances, so companies can do such gap analysis without worrying that they may be missing something.
 
4. Describe product changes
 
Maisel said sponsors need to be able to explain any differences between the device marketed under an EUA or enforcement discretion policies, and the last cleared or approved version of the device, if there are any.
 
“In other words, if they have modified a device that was already cleared or approved for marketing, they should understand what those modifications are,” Maisel said. “Obviously some EUA have never been cleared or approved, and that's fine, and that makes it very simple and easy for this step.”
 
Maisel noted that under some of FDA’s enforcement policies, companies are only allowed to modify products to an extent, and that they need to be able to describe what modifications they have made to their product to regulators.
 
5. Make a decision
 
After reviewing FDA’s regulatory expectations for transitioning products and evaluating any potential changes to their products from any predicates, Maisel said manufacturers need to decide whether to keep their device or diagnostic on the market.
 
“You now should have a lot of the information you need to be able to make a smart decision about whether you plan to pursue continued marketing of the device,” he said.
 
6. Make smart use of the pre-submission program
 
Maisel said companies who want to continue marketing their product and need to file a premarket application should consider smart use of the agency’s pre-submission process, though he emphasized that they aren’t obligated to use it. The process allows companies who want to submit premarket applications to have early interactions with the agency to help prepare their premarket application.
 
“If a company chooses to use it, they should use it smartly, and by that, I mean they should ask specific, focused questions that they feel need to be answered before they submit their application,” said Maisel. “Pre-submission questions that ask high-level vague questions are not particularly helpful either for FDA or for the sponsor.”
 
Maisel said it’s not helpful if a sponsor asks what they should do to test the biocompatibility of a device which can easily be found in guidances FDA has already issued on the topic. He said it’s a much better use of time and resources when sponsors have thought through their premarket application approach and come to the pre-submission meeting with more detailed questions.
 
Under the Medical Device User Fee Amendments (MDUFA V) program, FDA has committed to giving premarket application decisions for 90% of applications within 70 days; Maisel said sponsors should plan around that timeline.
 
“Using existing guidance, there are public summaries available for already cleared or approved similar devices that often include a summary of the type of testing that was performed, so those are often very helpful for companies who have similar devices and are trying to understand what type of testing would be expected of them,” Maisel recommended. “So, leveraging public 510(k) summaries or summaries of safety and effectiveness for [premarket approval] devices can be really helpful.”
 
7. Use eSTAR
 
Earlier this year, FDA announced it will require 510(k) submissions, unless exempted, to be submitted electronically using its electronic Submission Template And Resource (eSTAR) template starting in October 2023. The template is currently available for 510(k) and de novo applications but cannot be used for combination products.
 
While it is currently voluntary, Maisel highly encourages sponsors to use it to save everyone time and effort.
 
“eSTAR is a great tool that mirrors the review template that our staff use to evaluate devices, so it allows the sponsor to provide the information proactively,” said Maisel. “It walks them through what is expected it, it has help text to help sponsors through the submission and can be a really helpful tool for not only increasing submission quality, but helping the sponsor have a smoother experience with their review.”
 
Another benefit of using the eSTAR template for 510(k)s is that it bypasses the refuse to accept (RTA) phase of the submission process. The RTA is used as a quality checklist by reviewers to ensure there aren’t any missing elements of the submission; if there are, the submission is returned to the submitter.
 
“That becomes important when you start looking at the timelines of the transition plan because when we talk about the premarket submission due dates, that is dependent upon FDA receiving and accepting this submission,” said Maisel. “eSTAR can be a tool that can help, particularly for 510(k)s.”
 
8. Have a transition implementation plan
 
In the transition guidances, FDA recommends transitioning marketed and distributed products using risk-based plans based on product type.
 
For example, Maisel said that FDA expects single-use non-life-sustaining or life-supporting products to stay on the market until they’re consumed. On the other hand, reusable devices should have publicly available labeling that describes the products’ features and regulatory status.
 
“Companies should be thinking about how are they going to handle a product that is already distributed following either the withdrawal of the enforcement policies or upon termination of the EUA declaration,” said Maisel.
 
He said the FDA wants to hear from companies about their transition implementation plans, which should include a benefit-risk plan for what happens to already distributed products, and how they intend to notify consumers and health care providers about the products’ regulatory status.
 
9. Keep an eye out for changes in the final guidances
 
“We are intending to address some of the thoughtful comments we received in response to our draft guidances, and I would anticipate there will be some additional clarity over some of the items that people commented on,” said Maisel.
 
Maisel said he anticipates that FDA will address product labeling and the timeline for implementing UDI in the final guidance, though the general structure of the transition plan likely be retained.
 
10. Don’t wait to submit
 
Maisel said that FDA is seeing an uptick in the number of premarket submissions for products that sponsors want to transition.
 
“I anticipate we'll see a steady increase in the number of submissions we receive, and I anticipate we will also see a flood near the deadline,” he said.
 
Filing just before the deadline could be problematic, not just for FDA, but for companies too. If too many submissions come in at the same time, that could overburden the agency and lead to delays. On the other hand, companies that file earlier are more likely to get an answer sooner.
 
“It also gives sponsors a little bit of an opportunity if for some reason their submission is not accepted for review, they have additional time to make the necessary corrections and get in before the deadline,” said Maisel.
 
“We are giving some time for sponsors to prepare their submissions and submit them, and ultimately there will be a due date and a deadline, but it's certainly not necessary to wait until the last minute or the last day,” Maisel added. “I would encourage sponsors that are otherwise ready to submit to do so, and if they're not, then to plan now for submitting.”

 

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