Hardware Podcasts

#467: Combination Product Compliance: PMOA, 21 CFR Part 4 & QMS Alignment

Global Medical Device Podcast · 3 Aug 2026 · 35m · Episode 467

What this episode covers

Jim Fentress, Director of Regulatory Affairs at Galero (a Santa Group company), explains the regulatory complexities of combination products, focusing on how the Primary Mode of Action (PMOA) dictates FDA oversight. He details the challenges pharmaceutical companies face when integrating device Quality Management Systems (QMSR/ISO 13485) into their existing CGMP frameworks under 21 CFR Part 4. The discussion covers specific friction points like risk management alignment (AAMI TIR105 vs. ICH Q9), labeling classifications, and the critical need for transparent change control protocols between device manufacturers and pharma partners.

Most relevant to

established companies

Topics

Mentioned

Companies
Galero, Santa Group, FDA, CDRH, CDER, EMA, Greenlight Guru
Also
AAMI TIR105, ISO 14971, ICH Q9, ISO 13485, 21 CFR Part 4, 21 CFR Part 210, 21 CFR Part 211

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