A Regulatory Gap Analysis of FDA's Systems & Policies

Episode Thumbnail
00:00
00:00
This is a podcast episode titled, A Regulatory Gap Analysis of FDA's Systems & Policies. The summary for this episode is: <p>What’s missing in the current FDA regulatory framework? Are there areas and opportunities for improvement?</p><p>In this episode of the Global Medical Device Podcast Greenlight Guru founder and host Jon Speer talks to Mike Drues of Vascular Sciences about what an ideal regulatory system would look like, and provide a gap analysis of the FDA's current regulatory systems and policies for a more proactive perspective rather than a reactive approach.</p><h3><strong>Some of the highlights of this episode include:</strong></h3><ul><li>Mike expresses frustration over how the regulatory environment creates regulations retrospectively and reactively as opposed to proactively to prevent potential problems before they occur.</li><li>Why is corrective action/preventive action (CAPA) not called PACA? The emphasis should be put on preventive action, as opposed to corrective action.</li><li>The FDA’s 510(k) program is not perfect and there needs to be reform and adjustments. Products brought to market under the 510(k) should not have been.</li><li>The biggest problem with 510(k) is predicate creep. There’s room for improvement because the 510(k) is the workhorse of the medical device industry.</li><li>Mike advocates for communicating often and early on with the FDA, even though it is not always easy to communicate with the FDA.&nbsp;</li><li>Mitigate risk with a meeting because there is no way to ensure that the FDA views something as a wellness versus a medical device. The FDA has no formal mechanism to designate something as a wellness device.</li><li>"Change Creep" involves relatively minor changes made without notifying the FDA but through a Letter To File. Incremental and individual changes may be minor, but should not prevent innovation and improvement.</li><li>A personalized medicine pathway is needed because the FDA does not recommend the custom device exemption (CDE) as the perfect pathway. Personalized medicine is clearly the future for many reasons.&nbsp;</li></ul><h3><strong>Memorable quotes from Mike Drues:</strong></h3><p><em>“One of my many frustrations with the regulatory environment that we live in is that so much of the regulation that we have is created retrospectively, reactively.”</em></p><p><em>“As we all know, the 510(k) is the workhorse of the medical device industry.”</em></p><p><em>“I’m a huge advocate of communication with the FDA.”</em></p><p><em>“We have tons of regulation already. We don’t need more regulation. What we need is more people understanding the regulation that we already have and figuring out ways to apply it.”</em></p><h3><strong>Links:</strong></h3><p><a href="https://www.fda.gov/corrective-and-preventive-actions-capa" rel="noopener noreferrer" target="_blank">FDA - Corrective Action/Preventative Action (CAPA)</a></p><p><a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/overview-device-regulation" rel="noopener noreferrer" target="_blank">FDA - Overview of Device Regulation</a></p><p><a href="https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-notification-510k" rel="noopener noreferrer" target="_blank">FDA - Premarket Notification 510(k)</a></p><p><a href="https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/premarket-approval-pma" rel="noopener noreferrer" target="_blank">FDA - Premarket Approval (PMA)</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/general-wellness-policy-low-risk-devices" rel="noopener noreferrer" target="_blank">FDA - General Wellness</a></p><p><a href="https://www.fda.gov/medical-devices/quality-and-compliance-medical-devices/case-quality" rel="noopener noreferrer" target="_blank">FDA - Case for Quality</a></p><p><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/compliance-actions-and-activities/warning-letters" rel="noopener noreferrer" target="_blank">FDA - Warning Letters</a></p><p><a href="https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/inspection-references/fda-form-483-frequently-asked-questions" rel="noopener noreferrer" target="_blank">FDA - Form 483 FAQ</a></p><p><a href="https://www.fda.gov/medical-devices/premarket-submissions-selecting-and-preparing-correct-submission/de-novo-classification-request" rel="noopener noreferrer" target="_blank">FDA - De Novo Classification Request</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">FDA - Emergency Use Authorization (EUA)</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">FDA - Breakthrough Devices Program (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">FDA - Safer Technologies Program (STeP) for Medical Devices</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/custom-device-exemption" rel="noopener noreferrer" target="_blank">FDA - Custom Device Exemption (CDE)</a></p><p><a href="https://www.cms.gov/" rel="noopener noreferrer" target="_blank">Centers for Medicare and Medicaid Services (CMS)</a></p><p><a href="https://www.linkedin.com/in/michaeldrues" rel="noopener noreferrer" target="_blank">Mike Drues on LinkedIn</a></p><p><a href="https://www.greenlight.guru/academy" rel="noopener noreferrer" target="_blank">Greenlight Guru Academy</a></p><p><a href="https://virtual-summit.greenlight.guru/" rel="noopener noreferrer" target="_blank">The Greenlight Guru True Quality Virtual Summit</a></p><p><a href="https://www.greenlight.guru/podcast-mtqs" rel="noopener noreferrer" target="_blank">MedTech True Quality Stories Podcast</a></p><p><a href="https://www.youtube.com/channel/UCYfQsPqHW8H8mZ4xpM4gn1Q" rel="noopener noreferrer" target="_blank">Greenlight Guru YouTube Channel</a></p><p><a href="https://www.greenlight.guru/" rel="noopener noreferrer" target="_blank">Greenlight Guru</a></p>

DESCRIPTION

What’s missing in the current FDA regulatory framework? Are there areas and opportunities for improvement?

In this episode of the Global Medical Device Podcast Greenlight Guru founder and host Jon Speer talks to Mike Drues of Vascular Sciences about what an ideal regulatory system would look like, and provide a gap analysis of the FDA's current regulatory systems and policies for a more proactive perspective rather than a reactive approach.

Some of the highlights of this episode include:

  • Mike expresses frustration over how the regulatory environment creates regulations retrospectively and reactively as opposed to proactively to prevent potential problems before they occur.
  • Why is corrective action/preventive action (CAPA) not called PACA? The emphasis should be put on preventive action, as opposed to corrective action.
  • The FDA’s 510(k) program is not perfect and there needs to be reform and adjustments. Products brought to market under the 510(k) should not have been.
  • The biggest problem with 510(k) is predicate creep. There’s room for improvement because the 510(k) is the workhorse of the medical device industry.
  • Mike advocates for communicating often and early on with the FDA, even though it is not always easy to communicate with the FDA. 
  • Mitigate risk with a meeting because there is no way to ensure that the FDA views something as a wellness versus a medical device. The FDA has no formal mechanism to designate something as a wellness device.
  • "Change Creep" involves relatively minor changes made without notifying the FDA but through a Letter To File. Incremental and individual changes may be minor, but should not prevent innovation and improvement.
  • A personalized medicine pathway is needed because the FDA does not recommend the custom device exemption (CDE) as the perfect pathway. Personalized medicine is clearly the future for many reasons. 

Memorable quotes from Mike Drues:

“One of my many frustrations with the regulatory environment that we live in is that so much of the regulation that we have is created retrospectively, reactively.”

“As we all know, the 510(k) is the workhorse of the medical device industry.”

“I’m a huge advocate of communication with the FDA.”

“We have tons of regulation already. We don’t need more regulation. What we need is more people understanding the regulation that we already have and figuring out ways to apply it.”

Links:

FDA - Corrective Action/Preventative Action (CAPA)

FDA - Overview of Device Regulation

FDA - Premarket Notification 510(k)

FDA - Premarket Approval (PMA)

FDA - General Wellness

FDA - Case for Quality

FDA - Warning Letters

FDA - Form 483 FAQ

FDA - De Novo Classification Request

FDA - Emergency Use Authorization (EUA)

FDA - Breakthrough Devices Program (BDP)

FDA - Safer Technologies Program (STeP) for Medical Devices

FDA - Custom Device Exemption (CDE)

Centers for Medicare and Medicaid Services (CMS)

Mike Drues on LinkedIn

Greenlight Guru Academy

The Greenlight Guru True Quality Virtual Summit

MedTech True Quality Stories Podcast

Greenlight Guru YouTube Channel

Greenlight Guru