Episode 228  |  38:04 min  |  09.15.2021

Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc

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This is a podcast episode titled, Focusing on the Intent of the UDI Requirements from FDA's Final Guidance Doc. The summary for this episode is: <p>When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the accompanying draft guidance left much ambiguity and confusion among manufacturers who struggled to understand what it was, why it mattered, and what to even do with it.</p><p>In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the recently published final guidance document on the UDI system from FDA.</p><p>Listen as Jon and Mike provide clarity for manufacturers regarding the true intent of FDA's final guidance on the UDI system, explaining the nuances, benefits, and potential impact of UDI for medical devices and technologies in the US.</p><h3><strong>Some of the highlights of this episode include:</strong></h3><ul><li>What is a UDI? Companies have different formats, technologies, or options available, such as an automatic identification and data capture system, to add barcodes, quick response codes, or RFID chips to devices and other products.</li><li>Many companies are getting in trouble with the FDA because of some aspect of UDIs - whether it’s rejected regulatory submissions or manufacturing inspections generating 483 observations.</li><li>Mike believes the reason why is because many people are focusing on following the UDI regulation (and guidance) without understanding its intent.</li><li>Fundamental problems that companies are experiencing are not due to the details of UDI implementation, but not knowing or understanding the need to add UDIs to medical devices.</li><li>UDI identifies the specific product, manufacturer, and batch, lot, or serial number. UDI is for traceability in case there is a problem, complaint, or recall.</li><li>Challenges of implementing UDIs on labels include if the device is too small, software doesn’t include packaging, and patient compliance.</li><li>Unique vs. Universal: Does ‘unique’ as defined in UDI by the FDA universally match the European Union and other regulatory bodies? It’s unlikely that a global or universal device identifier will be standardized.</li></ul><h3><strong>Memorable quotes from this episode:</strong></h3><p><em>“It’s amazing to me how many companies, including some of my customers, are getting in trouble with FDA - whether it comes to regulatory submissions that are being rejected or manufacturing inspections that they’re getting 483 observations on because of some aspect of UDIs.” </em>Mike Drues</p><p><em>“It’s taking us, quite frankly, a heck of a long time to do something that Walmart was doing more than 20 years ago. Why the heck is it taking us so long?” </em>Mike Drues</p><p><em>“The gist of a UDI is to identify the specific product and manufacturer and potentially even the batch or lot or serial number of that product.” </em>Jon Speer</p><p><em>“This should not be a foreign concept to anybody. This is a concept of traceability - that’s all a UDI is - traceability.” </em>Mike Drues</p><h3><strong>Links:</strong></h3><p><a href="https://www.fda.gov/medical-devices/device-advice-comprehensive-regulatory-assistance/unique-device-identification-system-udi-system" rel="noopener noreferrer" target="_blank">FDA UDI Homepage: Unique Device Identification System</a></p><p><a href="https://www.fda.gov/regulatory-information/search-fda-guidance-documents/unique-device-identification-system-form-and-content-unique-device-identifier-udi" rel="noopener noreferrer" target="_blank">CDRH Guidance: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) (July, 2021)</a></p><p><a href="https://www.raps.org/news-and-articles/news-articles/2021/7/fda-finalizes-long-awaited-udi-guidance" rel="noopener noreferrer" target="_blank">FDA finalizes long-awaited UDI guidance (RAPS, July, 2021)</a></p><p><a href="https://www.emergobyul.com/blog/2021/08/brazils-new-udi-requirements-medical-devices-compliance-implications-manufacturers" rel="noopener noreferrer" target="_blank">Brazil’s new UDI requirements for medical devices: Compliance implications for manufacturers</a></p><p><a href="https://www.govinfo.gov/help/cfr" rel="noopener noreferrer" target="_blank">Code of Federal Regulations (CFR)</a></p><p><a href="https://www.fda.gov/medical-devices/premarket-notification-510k/510k-submission-process" rel="noopener noreferrer" target="_blank">FDA - 510(k) Submission Process</a></p><p><a href="https://www.fda.gov/medical-devices/digital-health-center-excellence/software-medical-device-samd" rel="noopener noreferrer" target="_blank">FDA - Software as a Medical Device (SaMD)</a></p><p><a href="https://www.fda.gov/medical-devices/premarket-submissions/premarket-approval-pma" rel="noopener noreferrer" target="_blank">FDA - Premarket Approval (PMA)</a></p><p><a href="https://www.abilify.com/" rel="noopener noreferrer" target="_blank">ABILIFY</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>

When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the accompanying draft guidance left much ambiguity and confusion among manufacturers who struggled to understand what it was, why it mattered, and what to even do with it.

In this episode of the Global Medical Device Podcast, Jon Speer talks to Mike Drues from Vascular Sciences about the recently published final guidance document on the UDI system from FDA.

Listen as Jon and Mike provide clarity for manufacturers regarding the true intent of FDA's final guidance on the UDI system, explaining the nuances, benefits, and potential impact of UDI for medical devices and technologies in the US.

Some of the highlights of this episode include:

  • What is a UDI? Companies have different formats, technologies, or options available, such as an automatic identification and data capture system, to add barcodes, quick response codes, or RFID chips to devices and other products.
  • Many companies are getting in trouble with the FDA because of some aspect of UDIs - whether it’s rejected regulatory submissions or manufacturing inspections generating 483 observations.
  • Mike believes the reason why is because many people are focusing on following the UDI regulation (and guidance) without understanding its intent.
  • Fundamental problems that companies are experiencing are not due to the details of UDI implementation, but not knowing or understanding the need to add UDIs to medical devices.
  • UDI identifies the specific product, manufacturer, and batch, lot, or serial number. UDI is for traceability in case there is a problem, complaint, or recall.
  • Challenges of implementing UDIs on labels include if the device is too small, software doesn’t include packaging, and patient compliance.
  • Unique vs. Universal: Does ‘unique’ as defined in UDI by the FDA universally match the European Union and other regulatory bodies? It’s unlikely that a global or universal device identifier will be standardized.

Memorable quotes from this episode:

“It’s amazing to me how many companies, including some of my customers, are getting in trouble with FDA - whether it comes to regulatory submissions that are being rejected or manufacturing inspections that they’re getting 483 observations on because of some aspect of UDIs.” Mike Drues

“It’s taking us, quite frankly, a heck of a long time to do something that Walmart was doing more than 20 years ago. Why the heck is it taking us so long?” Mike Drues

“The gist of a UDI is to identify the specific product and manufacturer and potentially even the batch or lot or serial number of that product.” Jon Speer

“This should not be a foreign concept to anybody. This is a concept of traceability - that’s all a UDI is - traceability.” Mike Drues

Links:

FDA UDI Homepage: Unique Device Identification System

CDRH Guidance: Unique Device Identification System: Form and Content of the Unique Device Identifier (UDI) (July, 2021)

FDA finalizes long-awaited UDI guidance (RAPS, July, 2021)

Brazil’s new UDI requirements for medical devices: Compliance implications for manufacturers

Code of Federal Regulations (CFR)

FDA - 510(k) Submission Process

FDA - Software as a Medical Device (SaMD)

FDA - Premarket Approval (PMA)

ABILIFY

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

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