Hardware Podcasts

211 - Inside FDA’s Office of Combination Products: History, PMOA, and What’s Next for Combination Products with Mark Kramer

Let's Combinate · 30 Oct 2025 · 46m

What this episode covers

Mark Kramer, founding director of the FDA’s Office of Combination Products (OCP) and now Principal at Eliquent Life Sciences, explains the history and regulatory framework for combination products in the U.S. He details how the 1990 Safe Medical Devices Act and the 2002 Medical Device User Fee and Modernization Act (MDUFA) led to the creation of OCP, driven initially by the device industry's need to regulate drug-eluting coronary stents. Kramer discusses the Primary Mode of Action (PMOA) rule, the shift from device-led to pharma-led combination products, and current regulatory gaps such as cross-labeling and site registration ambiguities.

Most relevant to

large enterprises

Topics

Mentioned

Companies
FDA, Eliquent Life Sciences, Greenleaf Health
Also
Office of Combination Products, Safe Medical Devices Act, MDUFA, PDUFA, 21 CFR 3.4, Part 4

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