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When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the accompanying draft guidance left much ambiguity and confusion among manufacturers who struggled to understand what it was, why it mattered, and what to even do with it.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When the Unique Device Identification (UDI) system was first announced by FDA several years ago, the accompanying draft guidance left much ambiguity and confusion among manufacturers who struggled to understand what it was, why it mattered, and what to even do with it.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