Device experts discuss breakthrough strategies and STeP submissions to Convergence

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Regulatory news

| September 26, 2022 | By Joanne S. Eglovitch

PHOENIX, AZ – Device makers planning to submit applications through the U.S. Food and Drug Administration’s (FDA) two new device programs, the Breakthrough Devices Program and the (SteP) for medical devices, should consider submitting clinical data with their applications and executive summaries of the operation of their devices, according to experts who spoke on a panel at RAPS 2022 Convergence on September 13 .

They also offered guidance on when is the best time to seek clearances and whether it is possible to use these avenues as opposed to the more traditional route of a pre-market approval (PMA) or a 510(k). ).

Kathy Herzog and Lisa Pritchard, regulatory consultants at DuVal & Associates, provided an update on these programs and shared some best practices for submitting applications through both programs.

Dramatic increase in breakthrough designations

Since the breakthrough program launched in 2018, the agency has granted breakthrough status to nearly 700 devices, with the FDA granting such requests 70% of the time, Herzog said.

FDA data shows that the number of breakthrough designations has increased significantly since 2018, from 55 designations in fiscal year 2018 to 206 in fiscal year 2021. In the first three quarters of fiscal year 2022 , the FDA has granted 129 breakthrough device designations.

Herzog attributes the huge 2020 to 2021 spike to a proposed rule from the Center for Medicare and Medicaid Services (CMS) that would have reimbursed breakthrough devices for four years. This rule has however been withdrawn and a new rule to replace it is awaited.

Most of these designations, 687, were granted by the FDA’s Center for Devices and Radiological Health (CDRH) and six were granted by the Center for Biologics Evaluation and Research (CBER).

Of the total number of breakthrough devices, only a small number, 54 or 8%, have been licensed or approved, including 20 premarket approval (PMA) applications, 17 de novo classifications and 15 510(k)s.

Herzog called the number “surprisingly low” and attributed it to the fact that the FDA is still working on the application bolus review process.

Most applications have mature clinical data

Herzog said that while the groundbreaking program does not require sponsors to submit clinical data, three-quarters of those applications contain clinical data, based on a review of company press releases.

This clinical data was “mature data” for breakthrough applications and drawn from randomized clinical trials and pilot trial data.

STeP considered the “stepson” of revolutionary approvals

Pritchard explained that the STEP program is considered the “stepchild” of the breakthrough program in that it covers devices that are not eligible for the breakthrough designation. Products covered by this program include those whose nature of disease or condition treated, diagnosed or prevented by the device is less serious than those included in the breakthrough program. To be eligible, the device must also be “reasonably expected” to improve the benefit-risk profile of a treatment or diagnosis through substantial safety innovations.

She said the FDA has provided “remarkably little data” on STEP, and that interest in this program is “a far cry from what we saw with the breakthrough program.” (RELATED: Safer technologies program finalized by the FDARegulatory guidance January 5, 2021)

Submit executive summaries in STeP applications

Pritchard said Step nominations are typically submitted as Q submission requests and added that executive summaries are often overlooked when presenting such submissions.

She added that it is “absolutely essential” to provide these summaries because “they tell the story of your submission. You’re not just providing the evidence that the guidance document asks you to have…FDA reviewers have so many cases going on at once that it’s impossible for them to be an expert on your product. You know your product and what it does, and you need to share that passion with the reviewer and share that advocacy with the reviewer.

When to submit

Pritchard said a common question she hears from sponsors about both programs is when to submit applications. She advised manufacturers to wait until their device is “no longer a prototype” and to wait until they have performance and characterization data to support the product.

She also told manufacturers to know the competitive landscape to help inform the timing of applications. “If there are competitors neck and neck with you, you have to demonstrate that you are more efficient than them.”

Alternatively, if there are no similar devices on the market, it may be best to wait and gather more evidence to support the claim.

Pritchard said that from a risk perspective, it might be better to consider going the traditional 510(k) or PMA approval route instead of going through a breakthrough approval. When seeking approval through Breakthrough Approval, manufacturers often have less pre- and post-market data for their products and assume more risk.

RAPS Convergence

© 2022 Society of Regulatory Affairs Professionals.

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