Episode 211  |  37:06 min  |  06.07.2021

Examining the HHS Proposal for Premarket Notification Exemptions

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This is a podcast episode titled, Examining the HHS Proposal for Premarket Notification Exemptions. The summary for this episode is: <p><span style="background-color: transparent; color: rgb(0, 0, 0);">What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS) proposal that impacts the medical device industry?</span></p><p><span style="background-color: transparent; color: rgb(0, 0, 0);">In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the HHS proposal, which focuses on down-classifying and exempting more than 80 types of devices such as exam gloves, thermometers, imaging systems, infusion pumps, and ventilators.</span></p><p><br></p><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Some highlights of this episode include:</strong></h3><ul><li><span style="background-color: transparent;">In January 2021, HHS declassified a number of medical devices without first consulting or notifying FDA. As a result, the reclassification initiative is on hold pending a review due to regulatory freeze.</span></li><li><span style="background-color: transparent;">The HHS proposal affects seven (7) Class I devices (all gloves) and eighty-three (83) Class II devices, such personal protective equipment (PPE) and thermometers.</span></li><li><span style="background-color: transparent;">It’s ironic that regulatory quality requirements apply to products but don’t seem to apply to processes that regulate those products. It’s another example of not practicing what you preach.</span></li><li><span style="background-color: transparent;">Some companies want FDA to require feedback before down classifying and exempting changes. Reasons why? Safety, efficacy, and competitive advantage.</span></li><li><span style="background-color: transparent;">Design controls, risk management, and quality management systems demonstrate that products are safe, effective, and meet indications for use.</span></li><li><span style="background-color: transparent;">Proceduralizing and establishing processes is a way to describe how you operate and run your business. Why are they perceived as bad things and barriers?</span></li><li><span style="background-color: transparent;">Recommended approach: begin with biology, engineering, then regulatory requirements.</span></li></ul><p><span style="background-color: transparent;"><span class="ql-cursor"></span></span></p><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Memorable quotes from this episode:</strong></h3><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“Changing medical device classification, whether we’re going down or up, doesn’t matter, without notifying or consulting the folks that are responsible for evaluating these medical devices...politics aside, Jon, it’s hard to connect those dots. What sense does that make?” </em><span style="background-color: transparent; color: rgb(0, 0, 0);">Mike Drues</span></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“You don’t have to have a Ph.D. in biomedical engineering...to appreciate that gloves and thermometers and other forms of PPE—these are not the most complicated kind of products in the world.”</em><span style="background-color: transparent; color: rgb(0, 0, 0);"> Mike Drues</span></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“It should not take a Ph.D. in biomedical engineering or an RAC after somebody’s name to appreciate that maybe it doesn’t make sense to lump gloves and thermometers into the same category as infusion pumps and ventilators.” </em><span style="background-color: transparent; color: rgb(0, 0, 0);">Mike Drues</span></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“Isn’t evaluating changes or the potential for changes, in this case in a medical device, always a good thing?” </em><span style="background-color: transparent; color: rgb(0, 0, 0);">Mike Drues</span></p><p><em style="background-color: transparent; color: rgb(0, 0, 0);">“Things like design controls and risk management and establishing a quality management system is all about science. It’s all about demonstrating that the product is safe, that it’s effective, and that it meets the indications for use.”</em><span style="background-color: transparent; color: rgb(0, 0, 0);"> Jon Speer</span></p><p><br></p><h3><strong style="background-color: transparent; color: rgb(67, 67, 67);">Links:</strong></h3><p><a href="https://www.linkedin.com/in/michaeldrues" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Mike Drues on LinkedIn</a></p><p><a href="https://www.vascularsci.com/" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Vascular Sciences</a></p><p><a href="https://www.hhs.gov/" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">U.S. Department of Health and Human Services (HHS)</a></p><p><a href="https://www.hhs.gov/about/news/2020/11/04/hhs-proposes-unprecedented-regulatory-reform-through-retrospective-review.html" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">HHS Proposal</a></p><p><a href="https://www.fda.gov/medical-devices" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">FDA - Medical Devices</a></p><p><a href="https://www.raps.org/news-and-articles/news-articles/2021/4/hhs-proposed-510k-exemption-proves-the-need-for-re" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">HHS’ proposed 510(k) exemption proves the need for regulatory science</a></p><p><a href="https://www.raps.org/news-and-articles/news-articles/2021/3/device-digital-health-firms-oppose-hhs-proposed-51" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Device, digital health firms oppose HHS’ proposed 510(k) exemptions</a></p><p><a href="https://www.raps.org/news-and-articles/news-articles/2021/4/fda-walks-back-trump-era-premarket-notification-ex" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">FDA walks back Trump-era premarket notification exemptions</a></p><p><a href="https://www.fda.gov/regulatory-information/selected-amendments-fdc-act/21st-century-cures-act" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">21st Century Cures Act</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="background-color: transparent; color: rgb(17, 85, 204);">Emergency Use Authorization (EUA)</a></p><p><a href="https://www.fda.gov/media/135138/download" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Overview of the 510(k) Process</a></p><p><a href="https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma" rel="noopener noreferrer" target="_blank" style="background-color: transparent; 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="background-color: transparent; color: rgb(17, 85, 204);">De Novo Classification Request</a></p><p><a href="https://www.youtube.com/channel/UCYfQsPqHW8H8mZ4xpM4gn1Q" rel="noopener noreferrer" target="_blank" style="background-color: transparent; color: rgb(17, 85, 204);">Greenlight Guru Academy</a></p><p><a href="https://www.youtube.com/channel/UCYfQsPqHW8H8mZ4xpM4gn1Q" rel="noopener noreferrer" target="_blank" style="background-color: transparent; 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="background-color: transparent; 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="background-color: transparent; color: rgb(17, 85, 204);">Greenlight Guru</a></p>

What are the pros, cons, and ramifications of the U.S. Department of Health and Human Services’ (HHS) proposal that impacts the medical device industry?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the HHS proposal, which focuses on down-classifying and exempting more than 80 types of devices such as exam gloves, thermometers, imaging systems, infusion pumps, and ventilators.


Some highlights of this episode include:

  • In January 2021, HHS declassified a number of medical devices without first consulting or notifying FDA. As a result, the reclassification initiative is on hold pending a review due to regulatory freeze.
  • The HHS proposal affects seven (7) Class I devices (all gloves) and eighty-three (83) Class II devices, such personal protective equipment (PPE) and thermometers.
  • It’s ironic that regulatory quality requirements apply to products but don’t seem to apply to processes that regulate those products. It’s another example of not practicing what you preach.
  • Some companies want FDA to require feedback before down classifying and exempting changes. Reasons why? Safety, efficacy, and competitive advantage.
  • Design controls, risk management, and quality management systems demonstrate that products are safe, effective, and meet indications for use.
  • Proceduralizing and establishing processes is a way to describe how you operate and run your business. Why are they perceived as bad things and barriers?
  • Recommended approach: begin with biology, engineering, then regulatory requirements.


Memorable quotes from this episode:

“Changing medical device classification, whether we’re going down or up, doesn’t matter, without notifying or consulting the folks that are responsible for evaluating these medical devices...politics aside, Jon, it’s hard to connect those dots. What sense does that make?” Mike Drues

“You don’t have to have a Ph.D. in biomedical engineering...to appreciate that gloves and thermometers and other forms of PPE—these are not the most complicated kind of products in the world.” Mike Drues

“It should not take a Ph.D. in biomedical engineering or an RAC after somebody’s name to appreciate that maybe it doesn’t make sense to lump gloves and thermometers into the same category as infusion pumps and ventilators.” Mike Drues

“Isn’t evaluating changes or the potential for changes, in this case in a medical device, always a good thing?” Mike Drues

“Things like design controls and risk management and establishing a quality management system is all about science. It’s all about demonstrating that the product is safe, that it’s effective, and that it meets the indications for use.” Jon Speer


Links:

Mike Drues on LinkedIn

Vascular Sciences

U.S. Department of Health and Human Services (HHS)

HHS Proposal

FDA - Medical Devices

HHS’ proposed 510(k) exemption proves the need for regulatory science

Device, digital health firms oppose HHS’ proposed 510(k) exemptions

FDA walks back Trump-era premarket notification exemptions

21st Century Cures Act

Emergency Use Authorization (EUA)

Overview of the 510(k) Process

Premarket Approval (PMA)

De Novo Classification Request

Greenlight Guru Academy

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

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