Hardware Podcasts

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

Global Medical Device Podcast · 16 Sept 2021 · 38m · Episode 228

What this episode covers

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.

Most relevant to

early-stage companies

Topics

Mentioned

Companies
Vascular Sciences, Greenlight Guru, Walmart
Products
Abilify, Duodenoscope
Tools
RFID, QR code
Also
FDA

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