What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program (BDP) and Safer Technologies Program for Medical Devices (STeP)?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Director of Regulatory Affairs for Proxima Clinical Research (CRO).

Together, Isabella and Jon discuss the FDA’s Breakthrough Devices Program and Safer Technologies Program and how manufacturers can determine if one or either is worth pursuing for their medical device. BDP is popular, STeP has the potential to be, but is not quite there yet given it’s a much newer program.

• BDP designations are for medical devices that treat or diagnose life-threatening or irreversibly debilitating conditions. 
• BDP designations have an improvement over the current standard of care, may be new technology, or modification of existing technology. BDP designations show or have the potential to show that they are more effective and safe.
• STeP is for medical devices and device-led combination products that improve the safety of currently available treatments or diagnostics that target an underlying disease or condition less serious than those eligible for BDP.
• FDA hones in on the indication statement for breakthrough devices. A general indication statement of intended use that is not indication specific is more likely along the lines of STeP, then it is a breakthrough device.
• BDP designation and STeP need to be their own usually distinct q-submissions. It’s a 60-day period between submission and final designation or denial. At day 30, most get a request for more information.
• Some of the drawbacks of the BDP and STeP process include engagement and interactions with the FDA that do not go as expected. 
• Consider reimbursement early on because it’s important. The Centers for Medicare and Medicaid Services (CMS) has paused the Medicare Coverage of Innovative Technology (MCIT) reimbursement for BDP designation. 

“When you have more of a general indication statement, it’s more of an intended use and not really indication specific, that’s probably more along the lines of STeP than it is a breakthrough device.”

“FDA really hones in on the indication statement for a lot of breakthrough devices.”

“Being safer than the current technology out there–having the STeP designation can be beneficial for them because that’s really their selling point.”

“The FDA’s bar can get a little bit higher for your clearance or approval because you’re focusing on specific language...and you’re basically making claims that need to be proven.”

Isabella Schmitt

Proxima CRO

Breakthrough Device Designation Reimbursement

FDA - BDP

FDA - STeP

STeP Guidance Document

510(k) Premarket Notification

Premarket Approval (PMA)

De Novo Classification Request

Q-Submission Guidance

European Union Medical Device Regulation (EU MDR)

Emergency Use Authorization (EUA)

Centers for Medicare and Medicaid Services (CMS)

Medicare Coverage of Innovative Technology (MCIT)

Medical Device User Fee and Modernization Act (MDUFMA)

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The Greenlight Guru True Quality Virtual Summit

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