Hardware Podcasts

#401: FDA’s Vital Role in ISO Standards: Ensuring Global MedTech Integrity

Global Medical Device Podcast · 10 Apr 2025 · 48m · Episode 401

What this episode covers

Sarah Moeller, co-chair of ISO Working Group 4 and regulatory expert, discusses the critical role of the FDA in shaping global medical device standards, specifically ISO 14155 and ISO 18969. She highlights the challenges posed by the FDA's temporary withdrawal from standards-writing committees due to administrative changes and the potential risks to global harmonization and patient safety. Moeller advocates for maintaining FDA engagement, understanding the impact of MDUFA fees, and encourages industry professionals to contact their congressional representatives to support regulatory infrastructure.

Most relevant to

large enterprises

Topics

Mentioned

Companies
Greenlight Guru, Medtronic, Abbott, Boston Scientific
Also
ISO 14155, ISO 18969, FDA, MDUFA, PDUFA, EU MDR

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