CDRH says new device submissions show MedTech sector’s strength

Now that the nation has transitioned out of the emergency phase of the Covid-19 pandemic, top officials at the US Food and Drug Administration’s (FDA) device center say they have seen a “resurgence” in novel device applications, indicating a healthy innovation ecosystem. The agency is also confident that companies will continue to transition their products with emergency use authorization (EUA) to traditional marketing authorizations, and that the center will meet its staffing commitments under the latest user fee deal.

Jeff Shuren, director of the Center for Devices and Radiological Health (CDRH), and William Maisel, chief medical officer and director of the Office of Product Evaluation and Quality at CDRH, recently co-authored a blog post noting that the center has seen an uptick in device innovation. They said that CDRH had received more novel device submissions in the past year than in any other period since the agency began tracking the data in 2015.

“We’ve had a fourfold increase in the annual number of novel device authorizations over the last decade,” Maisel told Focus.

While not all submissions eventually get authorized, Maisel said it’s a good sign that a significant number of novel devices will come to market in about six to nine months.

“In some respects, the novel device authorizations, they’re a lagging indicator, they’re the most important marker of success,” he added.

Novel device submissions include premarket approvals (PMAs), de novo requests, breakthrough 510(k)s, humanitarian device exemptions (HDEs) and novel EUAs.

Maisel said it was harder for sponsors to develop new devices during the pandemic as they faced many logistical barriers, including enrolling patients into clinical trials and conducting non-clinical studies. In some cases, there have also been staffing issues that have hindered sponsors from moving forward with their research.

“The pandemic as a whole really greatly impacted the MedTech device development pipeline, and we saw that in the number of novel device submissions,” said Maisel. “We saw it and heard it from manufacturers that were trying to develop devices and the challenges they were having.”

“I am sure there are products that won’t see the light of day because of some of the pandemic challenges,” he added. “But I think more of what we’re seeing was that there were delays due to the pandemic, and now that pipeline is opening up again.”

According to Maisel, novel device submissions dropped significantly starting in June 2021 and bottomed out in June 2022. Since then, the number of submissions has gone up 30% and is now 10% higher than at any time since 2015.

The novel device submissions represent a wide range of products, such as genetic tests for cancer diagnostics, peripheral interventions, arterial fibrillation, spinal implants, wearable technologies that use artificial intelligence/ machine learning (AI/ML) and other technologies for at-home use.

In addition to the influx of novel submissions, FDA is also working to keep some of the products that were authorized during the pandemic on the market.

FDA has developed a framework that allows products currently on the market under an EUA to transition to a conventionally marketed product. The agency has been encouraging manufacturers to prepare for the transition so that it is not faced with a last-minute mountain of applications and patients aren’t put at risk of losing access to therapies and diagnostics.

FDA published a final guidance earlier this year on how to transition EUAs, allowing products to stay on the market for 180 days after the sponsor has submitted an advanced notice of termination.

Maisel noted that so far, none of those advanced notices of termination have been issued. Still, the agency is working on them to ensure there’s a smooth transition and that consumers continue to have access to medical products. Maisel added that the agency has been talking with about half of EUA sponsors who need to transition their product to a conventionally marketed one.

“Some of that is through pre-submission meetings, some of that is through informal conversations, some of that is through conventional FDA submissions,” said Maisel. “Based on everything we’re seeing, we don’t expect a backlog. Part of that is the approach we’ve taken.”

“We feel the transition is progressing in an orderly fashion and we are not expecting or concerned about a backlog of submissions,” he added.

By now, Maisel said, companies should have figured out what FDA expects of them if they want to transition their EUA products. He added that they should reach out to FDA through the pre-submission program to get more clarity, if needed.

During the pandemic, Shuren warned that FDA staff were burning the candle at both ends, and said he was concerned that many may leave the agency to work in the private sector for better pay and better work-life balance. While retaining and hiring staff is still challenging, Maisel said the agency is optimistic about meeting the staffing levels that CDRH agreed to under the most recent Medical Device User Fee Amendments (MDUFA V) deal.

“We always worry about being able to pay our staff fairly and compete with others who want our talented staff and that our recruitment efforts are bearing fruit,” said Maisel. “We are onboarding staff, we are on pace to meet the growth that we planned under the MDUFA V agreement, and we’re optimistic that the hiring and retention efforts we have leave us well-positioned for what’s ahead.” RAPS.org