Episode Thumbnail
Episode 194  |  39:47 min

3 Systems of Risk for Medical Devices from FDA

Episode 194  |  39:47 min  |  04.07.2021

3 Systems of Risk for Medical Devices from FDA

00:00
00:00
This is a podcast episode titled, 3 Systems of Risk for Medical Devices from FDA. The summary for this episode is: <p><span style="color: rgb(0, 0, 0); background-color: transparent;">Why does the FDA have three systems in place to address and handle risk related to medical devices? Each system serves a different purpose, but are all three actually necessary?</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 Mike Drues from Vascular Sciences about FDA’s three systems of risk for medical devices and the unique interdependencies and distinctions between them.</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;">Three systems for medical device risk from FDA: product classification, significant vs. nonsignificant risk, software level of concern.</span></li><li><span style="background-color: transparent;">The FDA’s classification system handles risk by classifying medical devices as Class I, II, or III. The higher the class, the higher the risk. The lower the class, the lower the risk. Yet, risk is a broad subject and there are a ton of exceptions.</span></li><li><span style="background-color: transparent;">Also, classification numbers/levels used by the FDA in the United States do not translate in a linear way to those in the European Union (EU) and elsewhere. There are similar systems but different rules that are philosophically different.&nbsp;</span></li><li><span style="background-color: transparent;">The significant vs. nonsignificant risk system focuses on clinical trials for medical devices. All clinical evaluations of investigational devices, unless exempt, must have an approved investigational device exemption (IDE).</span></li><li><span style="background-color: transparent;">The software level of concern is important because it determines the level of documentation required for software development.&nbsp;</span></li><li><span style="background-color: transparent;">The default classification for any new medical device is Class III. If it’s a new device, it’s not well-established and the benefits and risks are relatively unknown.</span></li><li><span style="background-color: transparent;">When it comes to labeling, say anything as long as you can prove and support it. When technology stays the same but the labeling claim changes, risk changes.&nbsp;&nbsp;</span></li><li><span style="background-color: transparent;">The determination of significant or nonsignificant risk is not made by the FDA or Institutional Review Board (IRB), but the medical device company.</span></li><li><span style="background-color: transparent;">The software level of concern consists of Class a, b, and c. Does the software have no possibility of causing injury or damage to health? Is non-serious injury possible? Or, is serious injury or death possible?</span></li></ul><h3><strong style="color: rgb(67, 67, 67); background-color: transparent;">Memorable quotes by Mike Drues:</strong></h3><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“Theoretically, the classification of your medical device depends on risk. In other words, the higher the class, the higher the risk. The lower the class, the lower the risk.”</em></p><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“The default classification for any new medical device is Class III, which basically means we set the bar at the highest possible level.”</em></p><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“Oftentimes in regulation, we do things not because they make sense, but because that’s the way we’ve done them in the past.”&nbsp;&nbsp;</em></p><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“The determination of significant or nonsignificant risk is not up to the FDA. It’s not even up to your IRB, or Institutional Review Board, it’s up to the company.”</em></p><h3><strong style="color: rgb(67, 67, 67); background-color: transparent;">Links:</strong></h3><p><a href="https://www.fda.gov/medical-devices/overview-device-regulation/classify-your-medical-device" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">FDA - Classify Your Medical Device</a></p><p><a href="https://www.fda.gov/media/75459/download" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">FDA - Significant Risk and Nonsignificant Risk</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/guidance-content-premarket-submissions-software-contained-medical-devices" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">FDA - Software Level of Concern</a></p><p><a href="https://www.fda.gov/medical-devices/classify-your-medical-device/product-code-classification-database" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">FDA - Product Code Classification Database</a></p><p><a href="https://www.fda.gov/medical-devices/how-study-and-market-your-device/investigational-device-exemption-ide" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Investigational Device Exemption (IDE)</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/de-novo-classification-process-evaluation-automatic-class-iii-designation" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">De Novo Classification Process</a></p><p><a href="https://www.fda.gov/about-fda/fda-organization/center-devices-and-radiological-health" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Center for Devices and Radiological Health (CDRH)</a></p><p><a href="https://www.fda.gov/media/114034/download" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Requests for Feedback and Meetings for Medical Device Submissions</a></p><p><a href="https://www.linkedin.com/in/michaeldrues" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Mike Drues on LinkedIn</a></p><p><a href="https://www.greenlight.guru/webinar/de-novo-pathway" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru Webinar - Advanced Strategies and Tactics for Using the De Novo Pathway</a></p><p><a href="https://www.greenlight.guru/webinar/medical-device-classification-system" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru Webinar - Understanding the Medical Device Classification System</a></p><p><a href="https://www.greenlight.guru/blog/significant-risk-vs-nonsignificant-risk-devices" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Greenlight Guru Podcast EP 37: Significant Risk vs. Nonsignificant Risk Devices - What's the Difference?</a><span style="color: rgb(0, 0, 0); background-color: transparent;">&nbsp;</span></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>

Why does the FDA have three systems in place to address and handle risk related to medical devices? Each system serves a different purpose, but are all three actually necessary?

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about FDA’s three systems of risk for medical devices and the unique interdependencies and distinctions between them.

Some highlights of this episode include:

  • Three systems for medical device risk from FDA: product classification, significant vs. nonsignificant risk, software level of concern.
  • The FDA’s classification system handles risk by classifying medical devices as Class I, II, or III. The higher the class, the higher the risk. The lower the class, the lower the risk. Yet, risk is a broad subject and there are a ton of exceptions.
  • Also, classification numbers/levels used by the FDA in the United States do not translate in a linear way to those in the European Union (EU) and elsewhere. There are similar systems but different rules that are philosophically different. 
  • The significant vs. nonsignificant risk system focuses on clinical trials for medical devices. All clinical evaluations of investigational devices, unless exempt, must have an approved investigational device exemption (IDE).
  • The software level of concern is important because it determines the level of documentation required for software development. 
  • The default classification for any new medical device is Class III. If it’s a new device, it’s not well-established and the benefits and risks are relatively unknown.
  • When it comes to labeling, say anything as long as you can prove and support it. When technology stays the same but the labeling claim changes, risk changes.  
  • The determination of significant or nonsignificant risk is not made by the FDA or Institutional Review Board (IRB), but the medical device company.
  • The software level of concern consists of Class a, b, and c. Does the software have no possibility of causing injury or damage to health? Is non-serious injury possible? Or, is serious injury or death possible?

Memorable quotes by Mike Drues:

“Theoretically, the classification of your medical device depends on risk. In other words, the higher the class, the higher the risk. The lower the class, the lower the risk.”

“The default classification for any new medical device is Class III, which basically means we set the bar at the highest possible level.”

“Oftentimes in regulation, we do things not because they make sense, but because that’s the way we’ve done them in the past.”  

“The determination of significant or nonsignificant risk is not up to the FDA. It’s not even up to your IRB, or Institutional Review Board, it’s up to the company.”

Links:

FDA - Classify Your Medical Device

FDA - Significant Risk and Nonsignificant Risk

FDA - Software Level of Concern

FDA - Product Code Classification Database

Investigational Device Exemption (IDE)

De Novo Classification Process

Center for Devices and Radiological Health (CDRH)

Requests for Feedback and Meetings for Medical Device Submissions

Mike Drues on LinkedIn

Greenlight Guru Webinar - Advanced Strategies and Tactics for Using the De Novo Pathway

Greenlight Guru Webinar - Understanding the Medical Device Classification System

Greenlight Guru Podcast EP 37: Significant Risk vs. Nonsignificant Risk Devices - What's the Difference? 

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

Greenlight Guru YouTube Channel

MedTech True Quality Stories Podcast

Greenlight Guru

More Episodes

Why Demand is so High for Regulatory & Quality Jobs (and should you take advantage?)

Comparing FDA’s Breakthrough Devices Program & Safer Technologies Program

Why is IVDR Causing Widespread Panic throughout the Medical Device Industry?

Managing Business Risk as a Medical Device Company

Waterfall vs. Agile: Battle of the Product Development Methodologies

For the Love of Internal Auditing