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Episode 205  |  47:41 min

Regulatory Tips & Pointers from a Former FDA Reviewer

Episode 205  |  47:41 min  |  05.17.2021

Regulatory Tips & Pointers from a Former FDA Reviewer

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This is a podcast episode titled, Regulatory Tips & Pointers from a Former FDA Reviewer. The summary for this episode is: <p>As some veteran FDA reviewers leave and new ones are hired, knowledge is not always passed on seamlessly... To that end, regulatory professionals are often left to their own devices to find the guidance, support, and resources they need to fulfill their important roles in the medical device industry.</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 Allison Komiyama, a former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility evaluation. Listen to Allison share her thoughts on what she wishes she had known as an FDA reviewer, providing valuable insights for regulatory professionals in the medical device industry.</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;">New FDA reviewers are trying to navigate what’s important by asking questions because they have been working from home, never been onsite, and haven’t met their manager or other team members.</span></li><li><span style="background-color: transparent;">FDA managers are trying to make sure that their teams get the training and mentorship that they need, but it is difficult and challenging.</span></li><li><span style="background-color: transparent;">Deficiencies: What is four-part harmony? How are they written? List what was provided, what’s missing, what needs to be provided, and why is it needed?</span></li><li><span style="background-color: transparent;">It’s not only the lead reviewer looking at a regulatory submission, but a team of people. Review the deficiencies and manage the additional information (AI) letter to ask relevant questions.</span></li><li><span style="background-color: transparent;">To improve the speed of review and the time it takes for files, it’s important to support the reviewers and resources during that process.</span></li><li><span style="background-color: transparent;">There’s just not enough time for FDA reviewers to read through and understand all the guidance documents put out by the FDA. Include guidance documents in files to help the reviewers and express how regulations are being followed.</span></li><li><span style="background-color: transparent;">Recommendations for new reviewers: There’s what the regulation states, the legal definition, and then people's interpretation of the regulation, what does it mean and how does it apply?</span></li><li><span style="background-color: transparent;">There are different risks to different devices. For most questions, there are multiple correct answers that are acceptable by FDA. As a reviewer, you feel a huge burden of wanting to make sure nothing bad happens.</span></li></ul><h3><strong style="color: rgb(67, 67, 67); background-color: transparent;">Memorable Quotes from Allison Komiyama:</strong></h3><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“We’re kind of dealing with a lot of new reviewers who are trying to navigate being a new reviewer and what’s actually important. We can see that reflected in some of the questions that we’re getting.”&nbsp;</em></p><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“I think the managers at FDA are doing an amazing job trying to make sure that their teams get the training and the mentorship that they need while they are there. But it’s hard.”&nbsp;</em></p><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“Sometimes that knowledge doesn’t get passed on as seamlessly as we all would want. From the industry perspective, one of the most beneficial things that we can do to improve the speed of review and improve the time that our files take to go through that process is really to support the reviewers.”</em></p><p><em style="color: rgb(0, 0, 0); background-color: transparent;">“One of the things she didn’t realize when she was a new reviewer was how diligent a lot of us in industry are at keeping up on guidance and the changes in regulations because that’s my job. That’s what we do.”</em></p><h3><strong style="color: rgb(67, 67, 67); background-color: transparent;">Links:</strong></h3><p><a href="https://www.linkedin.com/in/allisonkomiyama" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Allison Komiyama on LinkedIn</a></p><p><a href="https://www.acknowledge-rs.com/" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Acknowledge Regulatory Strategies</a></p><p><a href="https://www.diaglobal.org/en/conference-listing/meetings/2020/05/regulatory-science-forum" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Regulatory Science Forum</a></p><p><a href="https://www.fda.gov/medical-devices" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">FDA - Medical Devices</a></p><p><a href="https://www.fda.gov/industry/fda-basics-industry/guidances" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">FDA - Guidance Documents</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);">Breakthrough Devices Program (BDP)</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);">Safer Technologies Program (STeP)</a></p><p><a href="https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">510(k) Submission Process</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-notification-510k/510k-submission-process" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Emergency Use Authorization (EUA)</a></p><p><a href="http://mrregulatory.com/about-us" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">David Pudwill (a.k.a. Mr. Regulatory)</a><span style="color: rgb(0, 0, 0); background-color: transparent;">&nbsp;</span></p><p><a href="https://www.fda.gov/medical-devices/medical-device-databases/code-federal-regulations-title-21-food-and-drugs" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Code of Federal Regulations (CFR) Title 21</a></p><p><a href="https://www.fda.gov/industry/fda-user-fee-programs/medical-device-user-fee-amendments-mdufa" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Medical Device User Fee Amendments (MDUFA)</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/use-international-standard-iso-10993-1-biological-evaluation-medical-devices-part-1-evaluation-and" rel="noopener noreferrer" target="_blank" style="color: rgb(17, 85, 204);">Use of ISO 10993-1 Biological Evaluation of Medical Devices</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>

As some veteran FDA reviewers leave and new ones are hired, knowledge is not always passed on seamlessly... To that end, regulatory professionals are often left to their own devices to find the guidance, support, and resources they need to fulfill their important roles in the medical device industry.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Allison Komiyama, a former FDA reviewer who is an expert in regulatory submissions, quality systems, and biocompatibility evaluation. Listen to Allison share her thoughts on what she wishes she had known as an FDA reviewer, providing valuable insights for regulatory professionals in the medical device industry.

Some highlights of this episode include:

  • New FDA reviewers are trying to navigate what’s important by asking questions because they have been working from home, never been onsite, and haven’t met their manager or other team members.
  • FDA managers are trying to make sure that their teams get the training and mentorship that they need, but it is difficult and challenging.
  • Deficiencies: What is four-part harmony? How are they written? List what was provided, what’s missing, what needs to be provided, and why is it needed?
  • It’s not only the lead reviewer looking at a regulatory submission, but a team of people. Review the deficiencies and manage the additional information (AI) letter to ask relevant questions.
  • To improve the speed of review and the time it takes for files, it’s important to support the reviewers and resources during that process.
  • There’s just not enough time for FDA reviewers to read through and understand all the guidance documents put out by the FDA. Include guidance documents in files to help the reviewers and express how regulations are being followed.
  • Recommendations for new reviewers: There’s what the regulation states, the legal definition, and then people's interpretation of the regulation, what does it mean and how does it apply?
  • There are different risks to different devices. For most questions, there are multiple correct answers that are acceptable by FDA. As a reviewer, you feel a huge burden of wanting to make sure nothing bad happens.

Memorable Quotes from Allison Komiyama:

“We’re kind of dealing with a lot of new reviewers who are trying to navigate being a new reviewer and what’s actually important. We can see that reflected in some of the questions that we’re getting.” 

“I think the managers at FDA are doing an amazing job trying to make sure that their teams get the training and the mentorship that they need while they are there. But it’s hard.” 

“Sometimes that knowledge doesn’t get passed on as seamlessly as we all would want. From the industry perspective, one of the most beneficial things that we can do to improve the speed of review and improve the time that our files take to go through that process is really to support the reviewers.”

“One of the things she didn’t realize when she was a new reviewer was how diligent a lot of us in industry are at keeping up on guidance and the changes in regulations because that’s my job. That’s what we do.”

Links:

Allison Komiyama on LinkedIn

Acknowledge Regulatory Strategies

Regulatory Science Forum

FDA - Medical Devices

FDA - Guidance Documents

Breakthrough Devices Program (BDP)

Safer Technologies Program (STeP)

510(k) Submission Process

Premarket Approval (PMA)

Emergency Use Authorization (EUA)

David Pudwill (a.k.a. Mr. Regulatory) 

Code of Federal Regulations (CFR) Title 21

Medical Device User Fee Amendments (MDUFA)

Use of ISO 10993-1 Biological Evaluation of Medical Devices

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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