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

- Show: [Global Medical Device Podcast](https://hardwarepodcasts.com/podcast/global-medical-device-podcast)
- Published: 2021-09-16
- Length: 38m
- Episode: 228
- Page: https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-16-focusing-on-the-intent-of-the-udi-requirements-from-fdas-final-guidance-doc
- Listen: https://podcast.greenlight.guru/episode/focusing-on-the-intent-of-the-udi-requirements-from-fdas-final-guidance-doc

## Summary

Mike Drues, a regulatory consultant from Vascular Sciences, joins host Jon Speer to discuss the intent behind the FDA's final guidance on Unique Device Identification (UDI). Drues argues that many manufacturers are failing because they focus on regulatory compliance details rather than the core principle of traceability, leading to rejected submissions and 483 observations. The conversation covers the various technologies available for UDIs, including barcodes, QR codes, and RFID chips, and highlights specific implementation challenges such as labeling tiny devices, software-as-a-medical-device (SaMD), and reusable equipment. Drues emphasizes that companies must apply a risk-based approach to labeling strategies, such as determining whether individual units within a multi-pack need unique identifiers, rather than waiting for prescriptive regulatory answers.

## Chapters

- [0:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-16-focusing-on-the-intent-of-the-udi-requirements-from-fdas-final-guidance-doc#t=0) Introduction: Jon Speer and Mike Drues on UDI Intent
- [2:02](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-16-focusing-on-the-intent-of-the-udi-requirements-from-fdas-final-guidance-doc#t=122) Defining UDI: Traceability, Barcodes, QR Codes, and RFID
- [7:51](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-16-focusing-on-the-intent-of-the-udi-requirements-from-fdas-final-guidance-doc#t=471) The Core Purpose: Traceability for Complaints and Recalls
- [13:47](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-16-focusing-on-the-intent-of-the-udi-requirements-from-fdas-final-guidance-doc#t=827) Beyond Recalls: Inventory Control and Compatibility Data
- [17:04](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-16-focusing-on-the-intent-of-the-udi-requirements-from-fdas-final-guidance-doc#t=1024) Implementation Challenges: Tiny Devices, Software, and Packaging
- [24:30](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-16-focusing-on-the-intent-of-the-udi-requirements-from-fdas-final-guidance-doc#t=1470) Global Standardization: FDA, EU, and the Lack of a Universal ID
- [28:00](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-16-focusing-on-the-intent-of-the-udi-requirements-from-fdas-final-guidance-doc#t=1680) Specific Use Cases: Implants, Reprocessable Devices, and Digital Pills
- [32:12](https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-16-focusing-on-the-intent-of-the-udi-requirements-from-fdas-final-guidance-doc#t=1932) Conclusion: Applying Risk-Based Logic to Labeling Requirements

## Topics

- [Certification & compliance](https://hardwarepodcasts.com/topic/certification-and-compliance)
- [Packaging design](https://hardwarepodcasts.com/topic/packaging-design)
- [Sensors & measurement in products](https://hardwarepodcasts.com/topic/sensors)
- [Quality & yield](https://hardwarepodcasts.com/topic/quality-and-yield)

## Most relevant to

early-stage companies

## Mentioned

- Vascular Sciences (company)
- Greenlight Guru (company)
- FDA (other)
- Walmart (company)
- RFID (tool)
- QR code (tool)
- Abilify (product)
- Duodenoscope (product)

## Related episodes from other shows

- [094 - Connected Combination Products, Product Traceability, Regulating New Products, Pre-Determined Changes and AI/ML with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-07-19-094-connected-combination-products-product-traceability-regulating-new-products) (Let's Combinate)
- [130 - QMSR Changes to Traceability/Reporting, Independent Reviewer & Risk Management, Learning New Regulations and MDSAP with Aaron Snyder](https://hardwarepodcasts.com/podcast/lets-combinate/2024-04-03-130-qmsr-changes-to-traceability-reporting-independent-reviewer-risk-management) (Let's Combinate)
- [139 - FDA Platform Guidance, EMA Q&A Guidance for Drug Device Combinations, USP and Sugar Badger 50k Race Recap with Subhi Saadeh](https://hardwarepodcasts.com/podcast/lets-combinate/2024-06-05-139-fda-platform-guidance-ema-q-a-guidance-for-drug-device-combinations-usp-and) (Let's Combinate)
- [079 - How FDA Reviews Combination Products, Policy, EPR's, and Harmonization with Rumi Young](https://hardwarepodcasts.com/podcast/lets-combinate/2023-04-05-079-how-fda-reviews-combination-products-policy-eprs-and-harmonization-with-rumi) (Let's Combinate)
- [Supply Chain Challenges in Medical Device Manufacturing](https://hardwarepodcasts.com/podcast/ontrack/2025-06-17-supply-chain-challenges-in-medical-device-manufacturing) (OnTrack)

## Citing this page

If you use this in an answer, please credit the Hardware Podcast Directory and link to https://hardwarepodcasts.com/podcast/global-medical-device-podcast/2021-09-16-focusing-on-the-intent-of-the-udi-requirements-from-fdas-final-guidance-doc. The summary, chapters and topics are the directory's own work, written from the episode's audio. The episode itself, its title and its audio belong to Global Medical Device Podcast.