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Episode 203  |  41:02 min

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

Episode 203  |  41:02 min  |  05.11.2021

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

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This is a podcast episode titled, Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program. The summary for this episode is: <p><span style="color: rgb(0, 0, 0); background-color: transparent;">What are the differences, similarities, and potential benefits of FDA’s Breakthrough Devices Program (BDP) and Safer Technologies Program for Medical Devices </span>(STeP)<span style="color: rgb(0, 0, 0); background-color: transparent;">?</span></p><p><span style="color: rgb(0, 0, 0); background-color: transparent;">In this episode of the Global Medical Device Podcast, Jon Speer talks to Isabella Schmitt, Director of Regulatory Affairs for Proxima Clinical Research (CRO).</span></p><p><span style="color: rgb(0, 0, 0); background-color: transparent;">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.</span></p><h3><strong style="color: rgb(67, 67, 67); background-color: transparent;">Some highlights of this episode include:</strong></h3><ul><li><span style="background-color: transparent;">BDP designations are for medical devices that treat or diagnose life-threatening or irreversibly debilitating conditions.&nbsp;</span></li><li><span style="background-color: transparent;">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.</span></li><li><span style="background-color: transparent;">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.</span></li><li><span style="background-color: transparent;">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.</span></li><li><span style="background-color: transparent;">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.</span></li><li><span style="background-color: transparent;">Some of the drawbacks of the BDP and STeP process include engagement and interactions with the FDA that do not go as expected.&nbsp;</span></li><li><span style="background-color: transparent;">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.&nbsp;</span></li></ul><h3><strong style="color: rgb(67, 67, 67); background-color: transparent;">Memorable quotes from Isabella Schmitt:</strong></h3><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“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.”</em></p><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“FDA really hones in on the indication statement for a lot of breakthrough devices.”</em></p><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“Being safer than the current technology out there–having the STeP designation can be beneficial for them because that’s really their selling point.”</em></p><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“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.”</em></p><h3><strong style="color: rgb(67, 67, 67); background-color: transparent;">Links:</strong></h3><p><a href="https://www.proximacro.com/team/isabella-schmitt" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Isabella Schmitt</a></p><p><a href="https://www.proximacro.com/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Proxima CRO</a></p><p><a href="https://www.proximacro.com/news/breakthrough-device-designation-reimbursement" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Breakthrough Device Designation Reimbursement</a></p><p><a href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/breakthrough-devices-program" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">FDA - BDP</a></p><p><a href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/safer-technologies-program-step-medical-devices" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">FDA - STeP</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/safer-technologies-program-medical-devices" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">STeP Guidance Document</a></p><p><a href="https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">510(k) Premarket Notification</a></p><p><a href="https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Premarket Approval (PMA)</a></p><p><a href="https://www.fda.gov/medical-devices/premarket-submissions/de-novo-classification-request" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">De Novo Classification Request</a></p><p><a href="https://www.fda.gov/media/114034/download" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Q-Submission Guidance</a></p><p><a href="https://eumdr.com/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">European Union Medical Device Regulation (EU MDR)</a></p><p><a href="https://www.fda.gov/emergency-preparedness-and-response/mcm-legal-regulatory-and-policy-framework/emergency-use-authorization" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Emergency Use Authorization (EUA)</a></p><p><a href="https://www.cms.gov/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Centers for Medicare and Medicaid Services (CMS)</a></p><p><a href="https://www.cms.gov/newsroom/fact-sheets/medicare-coverage-innovative-technology-cms-3372-f" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Medicare Coverage of Innovative Technology (MCIT)</a></p><p><a href="https://www.fda.gov/industry/medical-device-user-fee-amendments-mdufa/medical-device-user-fee-amendments-2023-mdufa-v" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Medical Device User Fee and Modernization Act (MDUFMA)</a></p><p><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru Academy</a></p><p><a href="https://virtual-summit.greenlight.guru/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">The Greenlight Guru True Quality Virtual Summit</a></p><p><a href="https://www.youtube.com/channel/UCYfQsPqHW8H8mZ4xpM4gn1Q" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru YouTube Channel</a></p><p><a href="https://www.greenlight.guru/podcast-mtqs" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">MedTech True Quality Stories Podcast</a></p><p><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru</a></p>

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.

Some highlights of this episode include:

  • 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. 

Memorable quotes from Isabella Schmitt:

“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.”

Links:

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)

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

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